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

NCT05007964 | Completed

• 1 other identifier: Spatz4-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Successful adjustment procedure at 16 ±2 weeks in > 90% of attempts

  Proportion of subjects with successful adjustment procedure is greater than 90%

  16±2 weeks

Study Arms (1)

Spatz4 subjects

EXPERIMENTAL

Subjects will be studied in an open label multi-center center study which will examine the usability of the adjustment process and success of the process. .

Device: Spatz4 Adjustable Balloon System

Interventions

Spatz4 Adjustable Balloon System DEVICE

The Spatz4 Adjustable Balloon System is designed to assist weight loss by partially filling the stomach and inducing satiety. The intragastrical balloon is implanted endoscopically for up to 12 months.

Spatz4 subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Spatz FGIA, Inc: lead

Study Sites (1)

Fundação do ABC - FMABC

Santo André, São Paulo, 09060-870, Brazil

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MANOEL GALVAO NETO, MD

  Fundação do ABC - FMABC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 17, 2021
• Study Start: June 14, 2022
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)