A Multi-Center Study to Evaluate the Adjustment Function of a Modified

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. Up to 66 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. An up adjustment will be performed at 16 weeks (±2 weeks). 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.

Clinical Trial 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 multi-center center study that will have one endpoint at 20 weeks. Up to 66 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. 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05007964
Study type	Interventional
Source	Spatz FGIA, Inc
Contact
Status	Completed
Phase	N/A
Start date	June 14, 2022
Completion date	April 5, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms