Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2025-12-17 @ 1:31 PM
Study NCT ID:
NCT04800835
Status:
None
Last Update Posted:
2022-11-28 00:00:00
First Post:
2021-03-10 00:00:00
Brief Title:
A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon
Sponsor:
Spatz FGIA Inc
Organization:
Spatz FGIA, Inc
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:
None
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:
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.
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 dieticians 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 09 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 09 normal saline as per section 162133 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 PINurse Practitioner and the DieticianNutritionist periodically as per section 173 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:
None
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?:
None