Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT07062094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '13 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Study Procedure-Related Adverse Events', 'timeFrame': 'Up to 13 months', 'description': 'Continuous assessment of safety of Orbera365™ IGB System by summarizing the occurrence of study device and study procedure-related Adverse Events through 30 days post balloon removal.'}, {'measure': 'Percent Total Body Weight Loss (% TBWL) at study visits through time of removal', 'timeFrame': 'Up to 12 months', 'description': 'Percent Total Body Weight Loss (% TBWL) at study visits through time of removal (no more than 12 months).'}, {'measure': 'Change in A1C', 'timeFrame': 'Up to 12 months', 'description': 'Change in Hemoglobin A1C from baseline'}, {'measure': 'Change in Insulin', 'timeFrame': 'Up to 12 months', 'description': 'Change in Insulin from baseline'}, {'measure': 'Change in Fasting Glucose', 'timeFrame': 'Up to 12 months', 'description': 'Change in Fasting Glucose from baseline'}, {'measure': 'Change in Total Cholesterol', 'timeFrame': 'Up to 12 months', 'description': 'Change in Total Cholesterol from baseline'}, {'measure': 'Change in Low-density lipoprotein (LDL)', 'timeFrame': 'Up to 12 months', 'description': 'Change in LDL from baseline'}, {'measure': 'Change in High-denisty lipoprotein (HDL)', 'timeFrame': 'Up to 12 months', 'description': 'Change in HDL from baseline'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'Up to 12 months', 'description': 'Change in Triglycerides from baseline'}, {'measure': 'Change in Alanine Transaminase (ALT)', 'timeFrame': 'Up to 12 months', 'description': 'Change in ALT from baseline'}, {'measure': 'Change in Alkaline Phosphatase (ALP)', 'timeFrame': 'Up to 12 months', 'description': 'Change in ALP from baseline'}, {'measure': 'Change in Aspartate aminotransferase (AST)', 'timeFrame': 'Up to 12 months', 'description': 'Change in AST from baseline'}, {'measure': 'Change in Albumin', 'timeFrame': 'Up to 12 months', 'description': 'Change in Albumin from baseline'}, {'measure': 'Change in Direct Bilirubin', 'timeFrame': 'Up to 12 months', 'description': 'Change in Direct Bilirubin from baseline'}, {'measure': 'Change in Total Bilirubin', 'timeFrame': 'Up to 12 months', 'description': 'Change in Total Bilirubin from baseline'}, {'measure': 'Change in systolic and diastolic blood pressures', 'timeFrame': 'Up to 12 months', 'description': 'Change in systolic and diastolic blood pressures from baseline'}, {'measure': 'Changes in severity of obstructive sleep apnea (OSA)', 'timeFrame': 'Up to 12 months', 'description': 'Changes in severity of OSA from baseline as measured by apnea-hypopnea index (AHI)'}, {'measure': 'Changes in Medications for Type 2 diabetes', 'timeFrame': 'Up to 12 months', 'description': 'Changes in Type 2 diabetes medication dose and frequency from Baseline'}, {'measure': 'Changes in Hypertension Medication', 'timeFrame': 'Up to 12 months', 'description': 'Changes in Hypertension Medication dose and frequency from baseline'}, {'measure': 'Changes in Cholesterol Mediciation', 'timeFrame': 'Up to 12 months', 'description': 'Changes in Cholesterol Medication dose and frequency from Baseline'}, {'measure': 'Changes in obstructive sleep apnea (OSA) Medication and/or Medical Treatment', 'timeFrame': 'Up to 12 months', 'description': 'Changes in OSA Medication dose and frequency and/or changes in Medical Treatment from Baseline'}], 'primaryOutcomes': [{'measure': 'Rate of Subjects with Serious Adverse Events', 'timeFrame': 'Up to 12 months', 'description': 'The rate of subjects with serious adverse events of interest associated with the extended length of the study device in-dwell time (between 6 and 12 months) and requiringe hospitalization, endoscopic or surgical intervention, or are life-threatening. Adverse events of interest include gastric outlet obstruction, spontaneous deflation that leads to obstruction, hyperinflation, and removal complications related to airway obstruction or esophageal laceration / perforation associated with compromised balloon integrity.'}, {'measure': 'Rate of Treatment Completers', 'timeFrame': 'Up to 12 months', 'description': 'The rate of Treatment Completers that achieve ≥10% percent Total Body Weight Loss (%TBWL) at time of study removal procedure. Treatment Completer is defined as maintaining device therapy for the prescribed maximum allowed in-dwell period (up to12 months) or successfully achieving weight loss goal (e.g., at least 5% TBWL) and an early device removal for a reason other than an adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orbera365', 'Intragastric Balloon', 'Obesity', 'Orbera365™ IGB System'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.', 'detailedDescription': "The study's objective is to confirm the safety of the Orbera365™ Intragastric Balloon (IGB) for extended in situ dwell time (from 6 months up to 12 months). This information can be collected from standard-of-care data. Up to ten (10) sites located in Europe are planned to participate in this registry. A minimum of 100 subjects are required for the registry. A maximum of 200 subjects may be enrolled into the registry.\n\nThe study population will include Obese patients ((Body Mass Index (BMI) 30-50 kg/m2)) who have already consented to receive the Orbera365™ IGB System, who previously failed to achieve and maintain weight loss with a supervised weight-control program.\n\nStudy subjects will also include obese and super obese patients (BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.\n\nThe duration of study participation is expected to be up to thirteen months from study placement procedure. The total treatment with the study device will be no more than 12 months from placement. A 30-day post-removal assessment will be performed following the study removal procedure. The subject will have completed the study upon the completion of the 30-day post-removal assessment, regardless of when the study removal procedure occurred."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include Obese patients (BMI 30-50 kg/m2) who have already consented to receive the Orbera365™ IGB System, who previously failed to achieve and maintain weight loss with a supervised weight-control program.\n\nStudy subjects will also include obese and super obese patients (BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is ≥ 18 years of age\n2. Subject meets the indicated population for the device according to the Instructions for Use (IFU) including obese patients with the BMI of 30-50 kg/m2 for weight loss and patients with BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities before obesity or another surgery, unless contraindicated.\n3. Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry\n\nExclusion Criteria:\n\n1. Subject is planning on becoming pregnant during the one year following study device placement\n2. Subject will complete follow-up visits at a location that the treating physician does not practice\n3. Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.\n4. Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.\n5. Subjects who have conditions that are contraindicated for Orbera365™ IGB System as per the IFU, including, but not limited to:\n\n * The presence of more than one IGB at the same time.\n * Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n * Potential upper gastrointestinal bleeding conditions\n * A large hiatal hernia of \\> 5cm or a hernia ≤ 5 cm associated with severe or intractable gastro- esophageal reflux symptoms\n * A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope\n * Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.\n * Gastric Mass.\n * Severe coagulopathy.\n * Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision.\n * Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery"}, 'identificationModule': {'nctId': 'NCT07062094', 'acronym': 'Orbera365', 'briefTitle': 'Safety and Effectiveness of Orbera365™ Intragastric Balloon System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry', 'orgStudyIdInfo': {'id': 'E7235'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intragastric Balloon', 'type': 'DEVICE', 'description': 'The Orbera365™ IGB System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance. The IGB is placed in the stomach and filled with sterile saline, causing it to expand into a spherical shape. The filled IGB is designed to occupy space and move freely within the stomach, potentially altering appetite and satiety to achieve weight loss.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Dana Charpentier, MD', 'role': 'CONTACT'}, {'name': 'Dana Charpentier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OB Klinika', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bobigny', 'country': 'France', 'contacts': [{'name': 'Gheorghe Airinei, MD', 'role': 'CONTACT'}, {'name': 'Ghorghe Airinei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Román Turró Arau, MD', 'role': 'CONTACT'}, {'name': 'Román Turró Arau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'EndoBes - Centre Medico Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Shay Caravaggio', 'role': 'CONTACT', 'email': 'shay.caravaggio@bsci.com', 'phone': '(508) 683-4000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}