Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-28 @ 11:16 AM
Study NCT ID:
NCT03610958
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single center, open-labeled single arm study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluation of the Device administration.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Normal Gastroscopic examination as assessed by an independent safety committee.'}, {'measure': "the change in subjects' weight presented as percent total body loss (%TBL)", 'timeFrame': 'Baseline, 12 weeks', 'description': 'Subjects loss of weight described as %TBL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'obesity'], 'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Study design to demonstrate the safety and performance of the Epitomee Device', 'detailedDescription': 'Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21 ≤ Age \\<65 years\n2. 28 \\< BMI ≤ 40 kg/m2\n3. Healthy subject\n4. Normal blood count and chemistry\n5. Subject is able and willing to give informed consent\n6. Subject is able and willing to participate in the study and follow protocol procedures\n\nExclusion Criteria:\n\nA. General health and medication\n\n1. Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results\n2. Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion\n3. Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion\n4. Taking thyroid hormone deficiency drugs (such as L-thyroxine)\n5. Hemoglobin level under 11 gm/dl\n\n B. Weight loss history and status\n6. Currently using pharmaceutical agents or food supplements for weight loss\n7. History of weight reduction of more than 5% of total body weight in the past 6 months\n8. Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating\\*\n\n C. Specific GI history and status\n9. History or evidence of any active liver disease. (abnormal liver functions: \\>1.5 times upper limit)\n10. Subject with Inflammatory Bowel Disease (IBD)\n11. Significant swallowing disorders\n12. Less than 3 natural bowel movements per week\n13. Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)\n14. Malabsorption disorders\n\n D. General\n15. History of food allergy according to PI decision\n16. Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study\n17. History of alcohol or drug abuse within 6 months of screening\n18. Mental disorders\n19. Currently participating in an ongoing clinical study'}, 'identificationModule': {'nctId': 'NCT03610958', 'briefTitle': 'Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epitomee medical'}, 'officialTitle': 'Prospective, Single Center, Open-labeled Single Arm Study, to Asses the Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss in Healthy Over Weight and Obese Subjects', 'orgStudyIdInfo': {'id': 'PRT-05-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epitomee Device arm', 'description': "A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety. The Device is composed of a 000 size standard capsule and the Tulip's proprietary Device, encapsulated within it.\n\nThe Device components are produced from approved pharmaceutical excipients / food additives / generally recognized as safe (GRAS )/ food contact materials which are used at high grade", 'interventionNames': ['Device: Epitomee Device']}], 'interventions': [{'name': 'Epitomee Device', 'type': 'DEVICE', 'otherNames': ['Tulip Device'], 'description': 'A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.', 'armGroupLabels': ['Epitomee Device arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'Haim Shirin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Data will be available within six months of study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcomes measures will be made available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epitomee medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}