Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000095864
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
1/02/2021
Date last updated
6/07/2024
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study investigating the safety and feasibility of embolising the left gastric artery to aid rapid weight-loss in morbidly obese patients awaiting elective surgery.
Scientific title
A pilot study investigating the safety and feasibility of embolising the left gastric artery to aid rapid weight-loss in morbidly obese patients awaiting elective surgery.
Secondary ID [1] 302146 0
None
Universal Trial Number (UTN)
Trial acronym
POWER SLIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 318781 0
Condition category
Condition code
Diet and Nutrition 316796 316796 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gastric artery embolisation (GAE).
Embolisation of gastrointestinal arteries is a safe and effective procedure that has been performed by interventional radiologists for many years to manage intractable GI bleeding.
Although GAE is currently performed for intractable gastric bleeding, indication for this project is unique, being a method to modulate hormones, suppress appetite and accelerate weight loss.
The embolisation procedure will be performed by an interventional radiologist. This involves accessing an artery in the wrist to selectively occlude the left gastric artery with microscopic spherical embolic particles while the patient is under general anesthetic.
This is a one time procedure and will take <60 minutes.
Intervention code [1] 318444 0
Treatment: Other
Intervention code [2] 318863 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324912 0
Safety of gastric embolisation procedure measured by occurrence of adverse events as reported by the patient and classified according to the Clavien Dindo classification. Known adverse events include: infection, damage to the blood vessels, haemorrhage, bruising, gastric ulceration, gastric infarction or perforation and non-target gastric or other intestinal embolisation.
Timepoint [1] 324912 0
Assessed at baseline, one week, two weeks, 1, 2 and 3 months post gastric artery embolisation procedure.
Primary outcome [2] 324913 0
Efficacy of gastric artery embolisation procedure measured by change in body mass index as assessed by height and weight ratio determined by stadiometer and balance scales respectively.
Timepoint [2] 324913 0
Body mass index assessed at baseline and 1, 2 and 3 months post gastric artery embolisation procedure.
Primary outcome [3] 325459 0
Efficacy of gastric artery embolisation procedure measured by change in body composition as assessed by bioelectrical analysis.
Timepoint [3] 325459 0
Body composition assessed at baseline and two weeks, 1, 2 and 3 months post gastric artery embolisation procedure.
Secondary outcome [1] 386177 0
Symptoms experienced in the days following the GAE procedure as assessed by in house questionnaire.
Symptoms assessed include: generalised abdominal pain, reflux/indigestion, nausea, constipation, diarrhoea, blood in stool, malanea (black stool), skin discolouration, hand or wrist symptoms and swelling or bleeding at the wrist puncture site.
Also assessed by patient-reported symptoms not otherwise specified.
Timepoint [1] 386177 0
Questionnaires at baseline and two weeks, 1, 2 and 3 months post gastric artery embolisation procedure.
Secondary outcome [2] 386178 0
Changes in patient-reported appetite and hunger over the course of the study as assessed by in-house questionnaire designed specifically for this study.
Timepoint [2] 386178 0
Questionnaire at baseline and 1, 2 and 3 months gastric artery embolisation procedure.
Secondary outcome [3] 386179 0
Changes in appetite and hunger as assessed by ghrelin measured by serum assay.
Timepoint [3] 386179 0
Measured at baseline and 2 weeks, 1, 2, and 3 months post gastric artery embolisation procedure.
Secondary outcome [4] 386180 0
Quality of life (QoL) over the course of the study, as measured by both IWQOL-Lite-CT and RAND-SP36 Health Survey questionnaires.
Timepoint [4] 386180 0
Assessed at baseline and 1, 2, and 3 months post gastric artery embolisation procedure.
Secondary outcome [5] 388040 0
Changes in cholesterol over the course of the study including total cholesterol, HDL and LDL as assessed by serum assay.
Timepoint [5] 388040 0
Measured at baseline and 2 weeks, 1, 2, and 3 months post gastric artery embolisation procedure.
Secondary outcome [6] 390685 0
Changes in appetite and hunger as assessed by leptin measured by serum assay
Timepoint [6] 390685 0
Measured at baseline and 2 weeks, 1, 2, and 3 months post gastric artery embolisation procedure.
Secondary outcome [7] 390686 0
Changes in blood glucose level over the course of the study as assessed by HbA1c measured by serum assay
Timepoint [7] 390686 0
Measured at baseline and 2 weeks, 1, 2, and 3 months post gastric artery embolisation procedure.

Eligibility
Key inclusion criteria
BMI over 35 and weight <200 kg awaiting elective surgery, non-bariatric operative candidates; adequate renal, hepatic and haematologic function; able to undergo an angiographic procedure; medically fit enough to undertake mild or moderate exercise, motivated to lose weight and adhere to prescribed dietary advice. Further, patients must have private health insurance to be included in this trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignancy; pregnancy; active H. pylori infection; autoimmune disease; history of inflammatory bowel disease; eGFR <35; allergy to intravenous contrast; severe cardiopulmonary dysfunction; serious mental health or mood modulating medication; previous oesophageal or gastric surgery; planned or interest in future bariatric surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This pilot study aimed to assess the safety and feasibility of the left gastric artery embolisation procedure in reducing weight in a small group of patients who needed to rapidly lose weight before elective surgery or for other medical reasons. Considering the recent emergence of effective medical therapies that achieve the same endpoints, such as Semaglutide and Liraglutide, the study investigators believe that the ability to recruit patients into the study will be reduced, and the overall clinical indication for gastric artery embolisation procedures will be diminished. Therefore, the investigators have decided to terminate the study. They anticipate no future need to investigate the safety and efficacy of gastric artery embolisation and that larger studies focused on this procedure for this particular indication will be unnecessary.
Date of first participant enrolment
Anticipated
31/03/2021
Actual
13/07/2021
Date of last participant enrolment
Anticipated
Actual
13/07/2021
Date of last data collection
Anticipated
30/12/2024
Actual
28/01/2022
Sample size
Target
6
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17328 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 31056 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 306574 0
Commercial sector/Industry
Name [1] 306574 0
Terumo Australia
Country [1] 306574 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Wesley Specialist Centre
Level 1
87 Lang Pde
Auchenflower 4066
QLD
Country
Australia
Secondary sponsor category [1] 307099 0
None
Name [1] 307099 0
Address [1] 307099 0
Country [1] 307099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306756 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 306756 0
Ethics committee country [1] 306756 0
Australia
Date submitted for ethics approval [1] 306756 0
23/06/2020
Approval date [1] 306756 0
13/11/2020
Ethics approval number [1] 306756 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104914 0
Dr Nicholas Brown
Address 104914 0
I-MED Radiology
Level 2
The Wesley Hospital
30 Chasely St
Auchenflower QLD 4066
Country 104914 0
Australia
Phone 104914 0
+61 07 33719588
Fax 104914 0
Email 104914 0
[email protected]
Contact person for public queries
Name 104915 0
Sepinoud Firouzmand
Address 104915 0
I-MED Radiology
The Wesley Hospital
87 Lang Pde
Auchenflower QLD 4066
Country 104915 0
Australia
Phone 104915 0
+61 07 33719588
Fax 104915 0
Email 104915 0
[email protected]
Contact person for scientific queries
Name 104916 0
Sepinoud Firouzmand
Address 104916 0
I-MED Radiology
The Wesley Hospital
87 Lang Pde
Auchenflower QLD 4066
Country 104916 0
Australia
Phone 104916 0
+61 07 33719588
Fax 104916 0
Email 104916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will be shared with the respective individual in the study, and publishing/sharing via conference presentations or journal articles is planned to share the cohort data publicly.


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.