Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Completed

Conditions studied: Obesity

In brief

A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.

Key facts

Study ID

NCT05086302

Run by

Spatz FGIA, Inc

People needed

537

Starts

2021-12-03

Expected to finish

2025-01-13

Last updated by the study team

2025-05-30

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 22 - 65
• BMI ≥ 35 and <40 kg/m2 or BMI of 30 to 34.9 kg/m2 with one or more major obesity- related comorbid conditions
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
• History of obesity (BMI ≥ 30) for at least 2 years
• History of failure with non-surgical weight loss methods
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
• Ability to give informed consent
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence. Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject's obstetrician.

You may not qualify if…

• Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
• Prior open or laparoscopic bariatric surgery.
• Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
• Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
• A gastric mass.
• A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
• Acid reflux symptoms to any degree that require more than one medication for symptom control.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
• Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
• Severe coagulopathy.
• Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Chronic abdominal pain
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
• Hepatic insufficiency or cirrhosis
• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
• Alcoholism or drug addiction.
• Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
• Patients who have BOTH:
• A previous history of a serotonin syndrome AND
• currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].

Where it is running

• Carson D Liu MD Medical Corp — Marina del Rey, California, United States
• JSAPA — Jupiter, Florida, United States
• Formation — Tampa, Florida, United States
• True You Weight Loss (Atlanta) — Atlanta, Georgia, United States
• Gastro Center of Maryland — Columbia, Maryland, United States
• The Silhouette Clinic — Germantown, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Reveal Weight Loss — Livingston, New Jersey, United States
• Weight Loss and Wellness Center — Livingston, New Jersey, United States
• New Jersey Bariatric Center — Springfield, New Jersey, United States
• New York Bariatric Group - Wayne Location — Wayne, New Jersey, United States
• Steven Batash, M.D., P.C. — New York, New York, United States
• True You Weight Loss — Cary, North Carolina, United States
• Atlantic Medical Group — Kinston, North Carolina, United States
• JourneyLite Physicians — Cincinnati, Ohio, United States
• NRHS Journey Clinic — Norman, Oklahoma, United States
• Basin Surgical — Midland, Texas, United States
• Endoscopic Wellness Center of America — Reston, Virginia, United States
• Advanced Gastroenterology & Hepatology of Greater Washington — Vienna, Virginia, United States
• Transform Weight Loss — Seattle, Washington, United States
• FRC Gastro — Bayamón, Puerto Rico, Puerto Rico
• GI Offices of Dr. Rodriguez and Dr. Osorio — Bayamón, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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