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Trial registered on ANZCTR
Registration number
ACTRN12624001218583p
Ethics application status
Submitted, not yet approved
Date submitted
24/08/2024
Date registered
4/10/2024
Date last updated
4/10/2024
Date data sharing statement initially provided
4/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and Feasibility of the actv-graft® Craniofacial Bioscaffold
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Scientific title
A Pilot Study to Determine the Safety and Feasibility of the actv-graft® Bioscaffold for use in Craniofacial Reconstruction patients
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Secondary ID [1]
312670
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ACTV-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Craniofacial defect
334650
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Condition category
Condition code
Surgery
331228
331228
0
0
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Surgical techniques
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Respiratory
331499
331499
0
0
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Other respiratory disorders / diseases
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Neurological
331500
331500
0
0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is a medical device. Participants undergoing a craniotomy/burr hole or rhinoplasty procedure will receive surgery with the use of the actv-graft bioscaffold instead of routine surgery. The bioscaffold is used for defect repair and restoration of anatomic contour following craniofacial procedures.
The actv-graft bioscaffold is implanted in the skull/nose of participants during cranial/nasal reconstruction. A sheet of Actv-graft bioscaffold is trimmed to size during surgery. It is inserted into the treatment area to fill the defect zone. (No need for sutures or other fixation devices)
The time taken to handle, modify and implant the actv-graft bioscaffold is estimated to be 5 - 10 minutes depending on the shape of the defect.
The duration of surgery may vary depending on the patient.
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Intervention code [1]
329196
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Treatment: Devices
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Intervention code [2]
329393
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Treatment: Surgery
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety
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Assessment method [1]
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Rate of adverse device effects over study period. Examples of adverse device effects include:
- implant displacement assessed with physical examination
- infection assessed with physical examination (e.g. redness, swelling) and microbiological investigations
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Timepoint [1]
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operatively, immediately post-operatively and at 1, 2, 3, 6, 12, 26 weeks post-operatively
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Secondary outcome [1]
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Ease of use
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Assessment method [1]
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Assessed by surgeons. Specific questions:
- Length of surgery
- In your opinion, what was the change in length of surgery time compared to routine/alternate procedures?
(no change in surgical time, increased surgical time by___ minutes, reduced surgical time by ___ minutes)
- Was the actv-graft bioscaffold easy to intra-operatively modify? Y/N comments
- Was the actv-graft bioscaffold easy to implant? Y/N comments
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Timepoint [1]
438227
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immediately post-operatively
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Secondary outcome [2]
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Restoration of anatomic contour
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Assessment method [2]
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PHYSICAL EXAMINATION
- Does the actv-graft treatment site feel smooth and even? Y/N describe..
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Timepoint [2]
438228
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1, 2, 3, 6, 12 weeks post-operatively
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Secondary outcome [3]
438229
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Satisfaction with surgery outcomes
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Assessment method [3]
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Self-report. Participants will be asked specific questions.
Questions for craniotomy participants:
Are you satisfied with the overall outcome of the surgery? Y/N comments
Are you happy with how your head feels after your procedure? Y/N comments
Are you happy with how your head looks after your procedure? Y/N comments
Questions for rhinoplasty participants:
Are you satisfied with the overall outcome of the surgery? Y/N comments
Are you happy with how your nose feels after your procedure? Y/N comments
Are you happy with how your nose looks after your procedure? Y/N comments
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Timepoint [3]
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26 weeks post-operatively
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Eligibility
Key inclusion criteria
1. Patients with defects up to 25mm diameter in the craniofacial skeleton created as a result of a surgical procedure (burr hole/craniotomy or rhinoplasty).
2. Patient deemed by the investigator to be a good candidate for augmenting routine closure and contouring of the craniomaxillofacial skeleton with a bioscaffold.
3. Age between 18 and 75 years.
4. Voluntary informed consent given prior to the performance of any study-specific procedures.
5. Psychosocially, mentally, and physically able to fully comply with the protocol including
adhering to follow up schedules and requirements and filling out forms.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unable to provide voluntary informed consent
2. Critical sized bony defects
3. Load bearing reconstruction of craniofacial skeleton
4. Acute traumatic injury
5. Patient is breast feeding
6. Active infection–systemic or local
7. Pregnant, or wishes to become pregnant during the duration of the study
8. Systemic infectious disease including AIDS, HIV, hepatitis
9. Rheumatoid arthritis or other autoimmune disease
10. Transphenoidal endoscopic surgery
11. Active malignancy. Malignancies that are in remission and do not require further treatment or
skin cancers such as non-melanoma skin carcinoma are permitted. Brain tumours not involving the skull and very unlikely to need local radiotherapy or chemotherapy within 6 months are also permitted.
12. Has a history of recent drug or alcohol abuse within the last 12 months.
13. Patient is a Prisoner.
14. Subject is currently participating in another research project.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
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Date of last data collection
Anticipated
30/10/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
317106
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Commercial sector/Industry
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Name [1]
317106
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Global Surgical Innovations Pty Ltd
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Address [1]
317106
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Country [1]
317106
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Global Surgical Innovations Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
319363
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None
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Name [1]
319363
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Address [1]
319363
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Country [1]
319363
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315855
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
315855
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https://bellberry.com.au/
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Ethics committee country [1]
315855
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Australia
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Date submitted for ethics approval [1]
315855
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17/07/2024
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Approval date [1]
315855
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Ethics approval number [1]
315855
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Summary
Brief summary
The present clinical investigation aims to investigate the safety and feasibility of a novel bioscaffold in patients requiring defect repair and restoration of anatomic contour in non-critical sized, non-load bearing portions of the craniofacial skeleton following routine craniofacial operations. This is a first-in-human pilot study for this bioscaffold. It is hypothesised that there are no serious adverse events associated with the actv-graft bioscaffold.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof James van Gelder
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Address
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NSW Health, Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
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Country
136002
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Australia
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Phone
136002
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+61297676416
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Fax
136002
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Email
136002
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[email protected]
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Contact person for public queries
Name
136003
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Paraskevi Drakoulidou
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Address
136003
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Sydney Spine Institute, Suite 107, 3 Railway Pde 2134 BURWOOD NSW
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Country
136003
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Australia
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Phone
136003
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+610297155007
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Fax
136003
0
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Email
136003
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[email protected]
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Contact person for scientific queries
Name
136004
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Dr Philip Boughton
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Address
136004
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Global Surgical Innovations, Suite 107, 3 Railway Pde 2134 BURWOOD NSW
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Country
136004
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Australia
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Phone
136004
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+61 02 97155007
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Fax
136004
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Email
136004
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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