|
|
| General |
| Study Status |
Hold |
Application Number /
Requirement Number |
P160001 S020/ PAS001 |
| Date Original Protocol Accepted |
07/05/2019
|
| Date Current Protocol Accepted |
|
| Study Name |
Obalon NTS Post-Approval Study
|
| Device Name |
Obalon Balloon System with Navigation Touch
|
| Clinical Trial Number(s) |
NCT03497910
|
| 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 Objectives |
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 |
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).
|
| Key Study Endpoints |
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
|
