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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-REDUCE PAS


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General
Study Status Progress Inadequate
Application Number P140012 / PAS001
Date Current Protocol Accepted 06/27/2017
Study Name OSB Lead-REDUCE PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary study objective is to demonstrate the safety of the

ReShape Dual Balloon treatment using a composite endpoint consisting of all device- and/or procedure-related serious adverse events (SAEs) including those associated with early device explants or deflations, gastric ulcers and esophageal trauma.



The study design is a prospective, new-enrollment, multicenter, single arm, open label clinical study.

Study Population Description Patients intending to have the ReShape procedure will be recruited

to include men and women 22 years of age and older with BMI =

30kg/m2 and = 40kg/m2 with one or more obesity-related

comorbidities.



The device group will act as its own comparator, with the device being removed after 24 weeks.

Sample Size 250 Intention to treat (ITT)/safety subjects will be enrolled at 10-15 sites in the US only (including ~4 from the pivotal trial sites) in order to have 223 weight-loss completed subjects at 24 weeks post device insertion and 182 weight-loss completed subjects at 48 weeks post- device insertion.



Assumptions:

CSE rate = 7.5% in REDUCE pivotal trial;

With a 1-sided upper confidence bound (UCB) of 0.975 and performance goal of 13%, an 80% power and normal approximation CIs result in an estimated sample size of 217 subjects.

Precision estimates/Confidence bounds for descriptive assessments:

1. % excess weight loss (%EWL) at 24 weeks:

Assuming an ITT 25.0 ± 21.0%EWL at 24 Weeks, a sample size of 250 will

provide a precision on the estimate of %EWL of 3.0 % with > 99% probability. For the Completer Cohort (n = 223) the precision will be 3.5% with > 99% probability.

2. % total body weight loss (%TBL) at 24 weeks:

Assuming an ITT 7.5 ± 5.5%TBL at 24 Weeks, a sample size of 250 will provide a precision on the estimate of %TBL of 1.0% with > 99% probability. For the Completer Cohort (n = 223) the precision will be 1.0% with > 99% probability.

3. Rate of gastric ulceration through the date of device retrieval: Assuming a rate of any device-related gastric ulceration of 10.5% using the modified tip (commercialized) device based on the REDUCE Pivotal and Single Arm studies,

a sample size of 250 will provide an exact binomial UCB of 14.9%

4. Rate of deflations through the date of device retrieval: Assuming a rate of any device deflation of 6.0% based on the REDUCE Pivotal Trial, a sample size of 250 will provide an exact binomial UCB of 9.7%

5. Rate of early retrievals: Assuming a rate of any retrieval occurring before

154 days of 15.0% based on the REDUCE Pivotal Trial, a sample size of 250

will provide an exact binomial UCB of 19.8%

6. Training and real world performance: for the comparison of safety rates between REDUCE Pivotal Trial (n=265) and ReShape PAS (n=250) a sample size of 250 subjects will achieve a precision of 6.5% or less with > 99% probability for the safety rates of interest (early retrievals and procedure- related SAEs).

*Note: subgroup assessments will be performed for the following: Extended Treatment subjects, Subjects Older Than Sixty, Obesity Drug Treatment subjects, subjects dichotomized by received fill volume (900cc/750cc), subjects dichotomized by age (<45, =45 years), subjects dichotomized by baseline BMI (<35kg/m2,

=35kg/m2) and sex, age and baseline BMI (<35kg/m2, = 35kg/m2)

Data Collection The primary safety endpoint is a composite of certain device- or procedure-related SAEs – CSE to include:

Any gastric ulcer SAE, any esophageal injury SAE, any device-related SAE (including those SAEs associated with deflations), any insertion/retrieval procedure-related SAE (including those SAEs associated with early retrievals).



The secondary/additional safety endpoints include:

1. The rates of each individual CSE component

2. Rate of all device retrievals prior to day 154

3. Rate of device deflations

4. Rate of all device-related gastric ulcers, SAE and non-SAE

5. Analysis of accommodative symptoms of nausea, vomiting, and/or abdominal pain using the prospective Rhodes Index of Nausea, and Abdominal Pain Visual Scale instruments.



There is no primary effectiveness endpoint



The secondary/additional effectiveness endpoints include:

1. Intent-To-Treat (with multiple imputation – ‘MI’) as last- observation-carried-forward (LOCF) – (for missing data) and Completed Cases weight loss characterization at weeks 24 and

48 (%EWL, %TBL, pounds lost and BMI unit reduction using all available data, and for 48 week data, comparison to 24 week values)

2. Subject satisfaction survey, Impact of Weight on Quality of Life

(IWQoL) and Three Factor Eating Questionnaire (TFEQ) at weeks

24, and 48.

Follow-up Visits and Length of Follow-up Follow-up will occur through 48 weeks (±2 weeks)


OSB Lead-REDUCE PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/27/2016 07/27/2016 On Time
18 month report 01/25/2017 01/27/2017 Overdue/Received
two year report 07/27/2017 07/28/2017 Overdue/Received
three year report 07/27/2018    
Final Report 01/31/2019    
four year report 07/27/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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