Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-03 @ 2:35 PM
Study NCT ID:
NCT02812160
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spatz Adjustable Balloon for Obesity (SABO)
Sponsor:
Spatz FGIA, Inc
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone
Status:
COMPLETED
Status Verified Date:
2021-05
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:
SABO
Brief Summary:
The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.
Detailed Description:
Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design: Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65, with a BMI ≥ 30 and \< 40 who have failed to achieve and maintain weight-loss with a weight control program Control group: Supervised diet and exercise Planned sample size: 282 subjects randomized 2:1 to device/control study treatment duration: 32 weeks Primary endpoint: Percent change in total body weight (%TBL) at 32 weeks
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: