Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06373666
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
Sponsor:
Spatz FGIA, Inc
Organization:
Study Overview
Official Title:
A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
Status:
RECRUITING
Status Verified Date:
2024-12
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 evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Detailed Description:
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Subjects will be studied in an open label study that will have one endpoint at 20 weeks. Up to 20 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 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 450 to 550 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. It is estimated, based on clinical studies, that approximately 10% of subjects will be intolerant in the first month and will require a down adjustment, wherein 150 ml of fluid will be removed from the balloon. An up adjustment will be performed at 16 weeks (±2 weeks) with the addition of 200-300 ml of 0.9% normal saline, as per section 1.7.2.1.3.3. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will be followed for 2 weeks after the up-adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
Subjects will be studied in an open label study that will have one endpoint at 20 weeks. Up to 20 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 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 450 to 550 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. It is estimated, based on clinical studies, that approximately 10% of subjects will be intolerant in the first month and will require a down adjustment, wherein 150 ml of fluid will be removed from the balloon. An up adjustment will be performed at 16 weeks (±2 weeks) with the addition of 200-300 ml of 0.9% normal saline, as per section 1.7.2.1.3.3. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will be followed for 2 weeks after the up-adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
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?: