Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Launched by SPATZ FGIA, INC · Oct 19, 2021

Keywords

ClinConnect Summary

The Spatz3 Adjustable Balloon System® study is looking at a new device to help adults with obesity who have struggled to lose weight using other methods. This trial focuses on individuals aged 22 to 65 who have a Body Mass Index (BMI) between 30 and 40 and may also have health issues related to their weight, like diabetes or high blood pressure. To be eligible, participants need to have a history of obesity for at least two years and must be willing to follow strict diet guidelines after receiving the device.

Participants in this study can expect to have the Spatz3 balloon placed in their stomach to help them feel full and eat less. They will need to attend regular follow-up visits and complete various health checks. It's important to know that certain medical conditions or previous surgeries might prevent someone from joining this trial, so potential participants should review the eligibility criteria carefully. Overall, the study aims to ensure that the safety of the Spatz3 device is similar to what was observed in earlier tests.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 22 - 65
• • 2. BMI ≥ 35 and \<40 kg/m2 or BMI of 30 to 34.9 kg/m2 with one or more major obesity- related comorbid conditions
• • 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
• • 4. History of obesity (BMI ≥ 30) for at least 2 years
• • 5. History of failure with non-surgical weight loss methods
• • 6. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling
• • 7. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
• • 8. Ability to give informed consent
• • 9. 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.
• Exclusion Criteria:
• • 1. Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
• • 2. Prior open or laparoscopic bariatric surgery.
• • 3. Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
• • 4. 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
• • 5. 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.
• • 6. A gastric mass.
• • 7. A hiatal hernia \> 2cm or severe or intractable gastro-esophageal reflux symptoms.
• • 8. Acid reflux symptoms to any degree that require more than one medication for symptom control.
• • 9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
• • 10. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
• • 11. Severe coagulopathy.
• • 12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
• • 13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• • 14. Chronic abdominal pain
• • 15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
• • 16. Hepatic insufficiency or cirrhosis
• • 17. 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.
• • 18. Alcoholism or drug addiction.
• • 19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• • 20. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
• • 21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• • 22. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
• 23. Patients who have BOTH:
• • 1. A previous history of a serotonin syndrome AND
• • 2. currently taking any drug known to affect the levels of serotonin in the body \[e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)\].
• • 24. Patients who are pregnant or breast-feeding.
• • 25. Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs
• • 26. Subjects who have tested positive for H. Pylori, and who have not yet been treated.
• • 27. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• • 28. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
• • 29. Subjects who are taking diet pills
• • 30. Use of an intragastric device prior to this study due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach.
• • 31. Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.
• • 32. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
• • 33. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• • 34. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
• • 35. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator because of an increased risk profile.
• • 36. Specific diagnosed genetic or hormonal cause for obesity such as untreated hypothyroidism or Prader Willi syndrome
• • 37. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• • 38. Known history of endocrine disorders affecting weight