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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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Obalon NTS Post-Approval Study


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General
Study Status Progress Adequate
Application Number P160001 S020/ PAS001
Date Current Protocol Accepted  
Study Name Obalon NTS Post-Approval Study
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 Design: New enrollment, single cohort group, prospective, observational, open-label, and multi-center study



Objective: To collect continued safety and performance of the Obalon Navigation-Touch System (NTS) in the commercial setting and confirm safety results observed in the pre-market approval IDE study.



Additionally, the study will evaluate the risk of esophageal inflation during balloon administration with the Obalon NTS.

Study Population Description The study will have a single cohort group that includes subjects who commercially purchased the Obalon Balloon System intended to be administered with NTS and have consented to have their data collected to support this study. Not all subjects who are consented are considered enrolled in the study. Subjects may be enrolled in the study after they meet all the eligibility criteria based upon demographics and commercial Obalon therapy eligibility. To be eligible for enrollment subjects must meet the following criteria:



Inclusion Criteria

The study will have a single cohort group that includes subjects who commercially purchased the Obalon Balloon System intended to be administered with NTS and have consented to have their data collected to support this study. Not all subjects who are consented are considered enrolled in the study. Subjects may be enrolled in the study after they meet all the eligibility criteria based upon demographics and commercial Obalon therapy eligibility. To be eligible for enrollment subjects must meet the following criteria:



Inclusion Criteria



Subjects may be included if they satisfy the following:



1. Ages 22 years and older

2. Starting therapy or current BMI of 30.0-40.0 kg/m2

1. Commercially purchased the Obalon Balloon Device



Exclusion Criteria



Subjects will be excluded if they satisfy the following:



1. Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett’s esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other

disorder of the esophagus.



2. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.



3. Known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.



4. Active implantable devices, such as a pacemaker or defibrillator, or with metal implants in the thoracic region.



Sites are required to maintain all the study activity records for every subject who signed an IRB approved informed consent and document the reason for every subject who does not meet all the enrollment eligibility criteria in the enrollment log. Sites will maintain a list of all subjects consented. All subjects that are enrolled will be entered into the Electronic Data Capture System.



Sample Size The study is to be performed at up to 40 sites in the United States. The study enrollment is a minimum of 3,951 balloon administrations with at least 1,317 balloon administrations for an individual balloon number (1st, 2nd, or 3rd) with Obalon NTS. Subject enrollment will include a minimum of one balloon administration and up to three total. The study will enroll a minimum of 1,400 and maximum of 1,600 subjects with least 1,000/1600 (at least 62.5%) subjects receiving all three balloons. Sites can perform up to 20% of the total study balloon administrations (approximately 792 evaluable balloon administrations or 264 for each individual balloon type).



Data Collection Primary and Secondary Endpoints

The study primary endpoint is to evaluate safety and performance of Obalon Balloon System administrations when using the Obalon Navigation/Touch System.

Co-Primary Endpoints

The endpoints will be evaluated based upon the percentage of Obalon Balloon administrations using the Obalon NTS with:

• For 100% of balloon administrations, there will be zero unexpected esophageal inflations and the 97.5% one-sided upper exact confidence bound for the estimated esophageal inflation rate is less than 0.1%;

• System Success, defined as appropriate inflation in the stomach with the use of the NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal. The endpoint is met if the one-sided 97.5% lower exact confidence bound is greater than 97%.



Follow-up Visits and Length of Follow-up No follow-up is included in the study


Obalon NTS Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/20/2019 07/24/2019 Overdue/Received
one year report 12/20/2019    
18 month report 06/19/2020    
two year report 12/19/2020    
three year report 12/19/2021    
four year report 03/29/2023    
five year report 12/19/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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