A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). (NCT06373666) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
Czechia20 participantsStarted 2024-08-09
Plain-language summary
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Have a BMI ≥ 27;
* Be male or female, between 18 and 65 years of age, inclusive;
* Have a history of excess weight (BMI ≥ 27 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
* Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
* Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 52 weeks);
* Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing, and must be willing to take prescribed proton pump inhibitors (PPIs);
* Be able to provide written informed consent;
* Have successful completion of the pre-placement screening and educational programs supporting that the subject is an appropriate study candidate;
* Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.
Exclusion Criteria:
* Previous history of esophageal, gastric or duodenal surgery, any bariatric surgery, any hiatal hernia surgery, bowel obstruction surgery, adhesive peritonitis, a…
What they're measuring
1
Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts.