Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-21 @ 12:30 AM
Study NCT ID:
NCT03688256
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obalon US Commercial Registry
Sponsor:
Surgical Specialists of Louisiana
Organization:
Study Overview
Official Title:
Obalon Balloon System: Real-World Evidence Commercial Site Registry
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
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:
None
Brief Summary:
Retrospective study of the data reported in the Obalon US Commercial Registry
Detailed Description:
Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.
Study Oversight
Has Oversight DMC:
False
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?: