Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-03 @ 2:35 PM
Study NCT ID:
NCT02812160
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spatz Adjustable Balloon for Obesity (SABO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeff@spatzmedical.net', 'phone': '1-516-303-0613', 'title': 'Jeffrey Brooks MD', 'organization': 'Spatz FGIA Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There are no overall Limitations and Caveats'}}, 'adverseEventsModule': {'timeFrame': '32 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Spatz3 Adjustable Balloon', 'description': 'Spatz3 Adjustable Balloon with Dietary and exercise counselling\n\nSpatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 184, 'seriousNumAtRisk': 187, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Control', 'description': 'Dietary and Exercise counselling', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 32, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2522, 'numAffected': 184}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 84, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastrointestinal disorders', 'notes': 'Nausea, Vomiting, Abdominal pain, Diarrhoea, Abdominal discomfort, Gastrooesophageal reflux , disease, Abdominal pain upper, Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 24, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'notes': 'Dehydration, Failure to thrive, Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Total Body Weight (%TBL) .', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spatz3 Adjustable Balloon', 'description': 'Spatz3 Adjustable Balloon with Dietary and exercise counselling\n\nSpatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary and Exercise counselling'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '32 weeks', 'description': 'The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.', 'unitOfMeasure': 'TBL%', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spatz3 Adjustable Balloon', 'description': 'Spatz3 Adjustable Balloon with Dietary and exercise counselling\n\nSpatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed'}, {'id': 'FG001', 'title': 'Control', 'description': 'Dietary and Exercise counselling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spatz3 Adjustable Balloon', 'description': 'Spatz3 Adjustable Balloon with Dietary and exercise counselling\n\nSpatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed'}, {'id': 'BG001', 'title': 'Control', 'description': 'Dietary and Exercise counselling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '44.0', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '44.3', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Body Mass Index BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres", 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The overall number of baseline participants does not differ from the number of participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-11', 'size': 1749916, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-04T12:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2020-10-20', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2016-05-25', 'dispFirstSubmitQcDate': '2020-11-11', 'resultsFirstSubmitDate': '2021-04-04', 'studyFirstSubmitQcDate': '2016-06-23', 'dispFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-05', 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Total Body Weight (%TBL) .', 'timeFrame': '32 weeks', 'description': 'The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['weight loss'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '34793746', 'type': 'DERIVED', 'citation': 'Abu Dayyeh BK, Maselli DB, Rapaka B, Lavin T, Noar M, Hussan H, Chapman CG, Popov V, Jirapinyo P, Acosta A, Vargas EJ, Storm AC, Bazerbachi F, Ryou M, French M, Noria S, Molina D, Thompson CC. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet. 2021 Nov 27;398(10315):1965-1973. doi: 10.1016/S0140-6736(21)02394-1. Epub 2021 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 22 - 65\n2. BMI ≥ 30 and \\<40\n3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure\n4. History of obesity (BMI ≥ 30) for at least 2 years\n5. History of failure with non-surgical weight loss methods\n6. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling\n7. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits\n8. Ability to give informed consent\n9. 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.\n\nExclusion Criteria:\n\n1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.\n2. Prior open or laparoscopic bariatric surgery.\n3. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.\n4. 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.\n5. 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.\n6. A gastric mass.\n7. A hiatal hernia \\> 2cm or severe or intractable gastro-esophageal reflux symptoms.\n8. Acid reflux symptoms to any degree that require more than one medication for symptom control.\n9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.\n10. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device\n11. Severe coagulopathy.\n12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.\n13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy\n14. Chronic abdominal pain\n15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation\n16. Hepatic insufficiency or cirrhosis\n17. 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.\n18. Alcoholism or drug addiction.\n19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.\n20. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.\n21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.\n22. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.\n23. 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.\n24. Patients who are pregnant or breast-feeding.\n25. 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\n26. Subjects who have tested positive for H. Pylori.\n27. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications\n28. Subjects who are taking corticosteroids, immunosuppressants, and narcotics\n29. Subjects who are taking diet pills\n30. 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.\n31. Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.\n32. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.\n33. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.\n34. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.\n35. 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.\n36. Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome\n37. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating\n38. Known history of endocrine disorders affecting weight"}, 'identificationModule': {'nctId': 'NCT02812160', 'acronym': 'SABO', 'briefTitle': 'Spatz Adjustable Balloon for Obesity (SABO)', 'organization': {'class': 'OTHER', 'fullName': 'Spatz FGIA, Inc'}, 'officialTitle': 'A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone', 'orgStudyIdInfo': {'id': 'Spatz-160061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spatz3 Adjustable Balloon', 'description': 'Spatz3 Adjustable Balloon with Dietary and exercise counselling', 'interventionNames': ['Device: Spatz3 Adjustable Balloon']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Dietary and Exercise counselling'}], 'interventions': [{'name': 'Spatz3 Adjustable Balloon', 'type': 'DEVICE', 'description': 'An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed', 'armGroupLabels': ['Spatz3 Adjustable Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Surgical Specialists of Louisiana', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Endoscopic MicroSurgery Associates', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Brigham and Womans Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Manhattan VA Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Barham AbuDayyeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Christopher C Thompson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spatz FGIA, Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}