A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon

NCT04800835 | Completed DMC

• 1 other identifier: Sp12Or6
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare a 12-month adjustable balloon over a 6-month non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Percent change in total body weight (%TBL) .

  Percent change in total body weight (%TBL) .

  12 months

Study Arms (2)

Group 1- Spatz3 adjustable balloon 12-month implantation;

ACTIVE COMPARATOR

A 12 month adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed

Device: Gastric Balloon

Group 2- 6-month non adjustable balloon implantation with additional 6 months follow-up

ACTIVE COMPARATOR

A 6-month non adjustable intragastric balloon for weight loss

Device: Gastric Balloon

Interventions

Gastric Balloon DEVICE

implantation of two types of gastric balloons. Spatz3 Adjustable balloon will be implanted for 12 months and 6-month non adjustable balloon will be implanted for 6 months

Group 1- Spatz3 adjustable balloon 12-month implantation;; Group 2- 6-month non adjustable balloon implantation with additional 6 months follow-up

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• 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;
• 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 device;
• 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)

Asclepiades - interna a gastroenterologie, s.r.o.

Havířov, 736 01, Czechia

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Gastric Balloon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Evžen Machytka, MD, PhD

  Asclepiades - Interna a Gastroenterologie, s.r.o.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - 6-month non adjustable balloon implantation with additional 6 months of dietician follow-up after balloon extraction

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: February 15, 2021
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)