Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT04800835
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon
Sponsor:
Spatz FGIA, Inc
Organization:
Study Overview
Official Title:
A Study to Compare the Safety and Effectiveness of the 12-month Spatz3 Adjustable Balloon With a 6-Month Non Adjustable Balloon in the Weight Management of Subjects
Status:
COMPLETED
Status Verified Date:
2022-07
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:
The purpose of this study is to compare a 12-month adjustable balloon over a 6-month non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months.
Detailed Description:
Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - non adjustable 6-month implantation with additional 6 months of dietician follow-up after balloon extraction. Fourth four eligible subjects will be randomized to treatment groups 1 and 2 and will undergo endoscopy and implantation of either the Spatz3 Adjustable Balloon or the 6-month non adjustable Balloon. All subjects will follow a calorie restricted diet designed by the dietician. The initial diet will be liquid and will be advanced as per the dietician's recommendations. Changes in diet will depend on subject tolerance to the balloon and specific food intolerances and will be adjusted frequently by the dietician. The initial balloon volume will be 500 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. An adjustment will be performed for treatment Group 1 at Week 24 (±6 weeks) with the addition of 200-300 ml of 0.9% normal saline, as per section 1.6.2.1.3.3. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will have follow up by the PI/Nurse Practitioner and the Dietician/Nutritionist periodically as per section 1.7.3. until extraction at 52 weeks. The 6-month non adjustable balloon treatment group will undergo balloon extraction at 6 months followed by monthly dietician vists for an additional 6 months. The study will terminate at the end of 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: