Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT03570034
Status:
UNKNOWN
Last Update Posted:
2020-04-30
First Post:
2018-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obalon Balloon System Post-Approval Study
Sponsor:
Obalon Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Obalon Balloon System - Post-Approval Study
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAS
Brief Summary:
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
Detailed Description:
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: