Obesity
Conditions
Keywords
weight loss
Brief summary
The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.
Detailed description
Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design: Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65, with a BMI ≥ 30 and \< 40 who have failed to achieve and maintain weight-loss with a weight control program Control group: Supervised diet and exercise Planned sample size: 282 subjects randomized 2:1 to device/control study treatment duration: 32 weeks Primary endpoint: Percent change in total body weight (%TBL) at 32 weeks
Interventions
DEVICESpatz3 Adjustable Balloon
An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed
Sponsors
Spatz FGIA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 22 - 65 2. BMI ≥ 30 and \<40 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. The method of birth control must be documented and verified at follow-up. 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 gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions. 2. Prior open or laparoscopic bariatric surgery. 3. Prior surgery of any kind on the esophagus, stomach 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 ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body \[e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)\] should not undergo placement of the device. 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. 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Total Body Weight (%TBL) . | 32 weeks | The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spatz3 Adjustable Balloon Spatz3 Adjustable Balloon with Dietary and exercise counselling
Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed | 187 |
| Control Dietary and Exercise counselling | 101 |
| Total | 288 |
Baseline characteristics
| Characteristic | Spatz3 Adjustable Balloon | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 187 Participants | 101 Participants | 288 Participants |
| Age, Continuous | 44.4 years STANDARD_DEVIATION 8.9 | 44.0 years STANDARD_DEVIATION 8.9 | 44.3 years STANDARD_DEVIATION 8.9 |
| BMI | 35.8 Kg/m^2 STANDARD_DEVIATION 2.6 | 35.8 Kg/m^2 STANDARD_DEVIATION 2.7 | 35.8 Kg/m^2 STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 26 Participants | 75 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 132 Participants | 72 Participants | 204 Participants |
| Region of Enrollment United States | 187 Participants | 101 Participants | 288 Participants |
| Sex: Female, Male Female | 162 Participants | 90 Participants | 252 Participants |
| Sex: Female, Male Male | 25 Participants | 11 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 187 | 0 / 101 |
| other Total, other adverse events | 184 / 187 | 32 / 101 |
| serious Total, serious adverse events | 10 / 187 | 1 / 101 |
Outcome results
Primary
Percent Change in Total Body Weight (%TBL) .
The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.
Time frame: 32 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spatz3 Adjustable Balloon | Percent Change in Total Body Weight (%TBL) . | 15.0 TBL% | Standard Deviation 7.2 |
| Control | Percent Change in Total Body Weight (%TBL) . | 3.3 TBL% | Standard Deviation 5.6 |