Evaluating the Spatz4 Adjustable Balloon for Weight Loss

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

This study is testing if the Spatz4 Adjustable Balloon can help people with a BMI of 27 or higher lose weight by adjusting the balloon and following a special diet for 20 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Spatz FGIA, Inc (Academic / other)
• Locations: 1 site (Havířov)
• Trial ID: NCT06373666 on ClinicalTrials.gov

What this trial studies

This study aims to assess the adjustment function of the Spatz4 Adjustable Balloon in individuals with a BMI of 27 or higher. Participants will undergo an endoscopic procedure to implant the balloon and will follow a calorie-restricted diet supervised by a dietician. The study will monitor the subjects over a 20-week period, with adjustments to the balloon's volume based on individual tolerance and dietary needs. The goal is to evaluate the effectiveness of this intervention in promoting weight loss.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a BMI of 27 or higher who have previously struggled with weight loss through traditional methods.

Not a fit: Patients who are not overweight or obese, or those who have not failed conservative weight-reduction alternatives, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a new method for individuals struggling with obesity to achieve significant weight loss.

How similar studies have performed: Previous studies involving adjustable gastric balloons have shown varying degrees of success, indicating that this approach has been tested but may still offer novel insights with the Spatz4 system.

Eligibility criteria

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, and/or hiatal hernia \> 4 cm;
* A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g. atrial fibrillation);
* History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
* History or symptoms of inflammatory bowel disease, such as Crohn's disease;
* History of unstable thyroid disease;
* History of uncontrolled gastro-esophageal reflux;
* Type I diabetes;
* History of dysphagia, esophageal stricture or esophageal food impaction;
* Poor general health, in the opinion of the Placing and/or Evaluating Investigator, or presence of a specific medical condition that would increase the risks associated with endoscopy and/or placement of the Spatz4;
* Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
* Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD);
* Specific diagnosed genetic or hormonal cause for obesity such as Prader Willi syndrome
* History or symptoms of esophageal or GI motility disorders (e.g., gastroparesis, achalasia, diffuse esophageal spasm) or symptoms of esophageal stricture;
* Ongoing treatment with anticoagulants, steroids, aspirin \> 100 mg, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants, and inability or unwillingness to discontinue the use of these concomitant medications;
* Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse;
* Pregnancy, breast-feeding, or intention of becoming pregnant during the study (if female of childbearing potential);
* A condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Where this trial is running

Havířov

• Endohope Havířov s.r.o. — Havířov, Czechia (Recruiting)

Study contacts

• Study coordinator: Evžen Machytka, MD

Conditions Overweight and Obesity