Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01386905




Registration number
NCT01386905
Ethics application status
Date submitted
30/06/2011
Date registered
1/07/2011
Date last updated
12/03/2014

Titles & IDs
Public title
A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects
Scientific title
A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (ENDObesity™ I Study)
Secondary ID [1] 0 0
TPSS-I-0409-B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BAROnova™ TransPyloric Shuttle™ (TPS™)

Treatment: Devices: BAROnova™ TransPyloric Shuttle™ (TPS™)
Subjects will undergo an endoscopic procedure to deliver the TPS™ into the stomach. The TPS™ moves freely without any physical attachment or invasive anchoring to tissue to reduce gastric outflow.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of the TransPyloric Shuttle™ System (TPS™)
Timepoint [1] 0 0
Up to 6 months post-placement
Secondary outcome [1] 0 0
Effect of the TransPyloric Shuttle™ (TPS™) on Patient Quality of Life
Timepoint [1] 0 0
Up to 6 months post-placement
Secondary outcome [2] 0 0
Safety of the TransPyloric Shuttle™ (TPS™)
Timepoint [2] 0 0
Up to 6 months post-placement

Eligibility
Key inclusion criteria
1. Male and female subjects between the ages of 18 to 55.
2. BMI between 30 to 50 kg/m2. Subjects with BMI = 35 to 50 kg/m2 inclusive, and subjects with a BMI of 30.0 to 34.9 kg/m2 are required to have one or more of the following obesity-related co-morbidities.

1. Diabetes: controlled diabetic, and if on insulin, has been on the medication of less than two years.
2. Sleep apnea: Apnea/hypopnea index or AHI > 30 events/hour.
3. Hypertension: arterial blood pressure > 140 mmHg systolic or > 90 mmHg diastolic
4. Osteoarthritis of the hip or knee.
5. Gastro Esophageal Reflux Disease (GERD): Persistent reflux that occurs more than twice a week.
3. History of stable weight (defined as a < 10% change in excess weight) for one year prior to screening visit.
4. Female subjects of childbearing potential must have a negative urine pregnancy test and must agree to practice a medically acceptable form of birth control for the duration of their participation in the trial.
5. History of obesity for at least five years.
6. Subjects must be able to read and understand their native language at a level allowing the subject to understand and sign the informed consent prior to the performance of any study-specific procedure.
7. Lives within the drawing area of the hospital.
8. Willing and able to return for all study visits.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently untreated thyroid and adrenal gland disease.
2. Females who are either pregnant or breastfeeding.
3. Insulin-dependent diabetic, where the subject has been on medication for more than two years.
4. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg.
5. Ischemic heart disease.
6. Previous stroke.
7. Previous myocardial infarct within 180 days of the study.
8. Prior history of bariatric surgery, such as gastric bypass, or any surgery that has altered the esophagus, stomach, or pylorus, and restrictive procedures such as the LAP-BAND® or equivalent.
9. Prior treatment with an intragastric balloon for the purpose of weight loss, where the balloon was removed less than 12 months prior to screening.
10. A structural abnormality in the esophagus, pharynx (such as a stricture), or pylorus (such as an incompetent pylorus).
11. Portal hypertension, cirrhosis, and/or varices.
12. Inflammatory disease, such as Crohn's disease, where the disease is affecting the stomach.
13. Acute abdominal infections.
14. Active gastric or duodenal ulcer.
15. A history of severe dyspepsia or gastric or duodenal ulcer disease.
16. After treatment for H. pylori, patient still tests positive for H. pylori.
17. Evidence of erosive esophagitis.
18. Subject with a hiatal hernia = 2 cm.
19. Subjects with motility disorders of the GI tract such as esophageal motility disorders, gastroparesis diabeticorum, or intractable constipation.
20. Use of any prescription or over-the-counter weight loss medication, including herbal supplements, within three months of TPS device placement.
21. Subjects requiring continuous therapy with known ulcerogenic medication (e.g. aspirin, including 80 mg ASA or NSAIDs).
22. Subjects on anticoagulant therapy, such as those taking Coumadin, Warfarin, Heparin or Plavix.
23. Subjects unable to take a daily 40+ mg dose of Nexium or generic equivalent or 800+ mcg of Misoprostol or general equivalent.
24. Clinically significant abnormal laboratory values or EKG that make the subject a poor study candidate in the opinion of the investigator.
25. Subjects with autoimmune connective tissue disorders.
26. A history of cardiac arrhythmia or severe cardiac disease (NYHA Class III or IV).
27. Cannot walk at least 0.8 kilometers per day (10 minutes of continuous walking).
28. Subjects who have started on a prescribed concomitant medication regimen within the last three weeks, and/or whose concomitant medication regimen is expected to change during the course of the study, and where the Investigator determines the medication may affect the study outcome.
29. Treatment for drug abuse, alcohol abuse, or inpatient psychiatric treatment within the past year.
30. Any medical condition (including psychiatric disease) that would interfere with the interpretation of the study results, the conduct of the study, or would not be in the best interest of the subject.
31. A score of = 10 on the Patient Health Questionnaire 9 (PHQ-9), indicating moderate depression.
32. Subjects who are in a dysfunctional relationship (e.g. an alcoholic spouse, the victim of sexual, verbal, or physical abuse, etc.).
33. Participation in a trial of an investigational drug or device within 30 days prior to Screening Visit or plans to enroll in an investigational drug or device trial at any time during this study.
34. Works for BAROnova or the study doctor or is directly-related to anyone that works for BAROnova or the study doctor.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Gastric Balloon Australia (GBA) - Bondi Junction
Recruitment postcode(s) [1] 0 0
2022 - Bondi Junction

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BaroNova, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
George Marinos, MD
Address 0 0
Gastric Balloon Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal http://www.oecd.org/document/16/0,2340,en_2649_346... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01386905