Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-05 @ 12:37 PM
Study NCT ID:
NCT01880918
Status:
UNKNOWN
Last Update Posted:
2013-06-19
First Post:
2013-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004241', 'term': 'Diverticulum, Colon'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D012005', 'term': 'Rectal Prolapse'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D045822', 'term': 'Intestinal Volvulus'}], 'ancestors': [{'id': 'D004240', 'term': 'Diverticulum'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D014102', 'term': 'Torsion Abnormality'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-16', 'studyFirstSubmitDate': '2013-06-16', 'studyFirstSubmitQcDate': '2013-06-16', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of anastomotic leakage.', 'timeFrame': '6 weeks after the procedure', 'description': 'Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.'}], 'secondaryOutcomes': [{'measure': 'Rate of other device related complications and measures during hospitalization and post procedure.', 'timeFrame': '6 weeks after the procedure.', 'description': 'The Following complications will be examined:\n\nBleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess) Readmission, re-operation, death within two months of the procedure Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)\n\nThe following post operative measures will be reported:\n\nHospitalization duration (two dates will be recorded: ready for discharge and discharge). The latter noting where the patient was discharged to - e.g. nursing home or home. First day to first postoperative flatus. First day to first postoperative bowel movements. First day of first postoperative toleration of liquids and solids (time to "keeping them down")'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Compression Anastomosis'], 'conditions': ['Diverticulum, Colon', 'Colorectal Neoplasms', 'Crohn Disease', 'Colitis, Ulcerative', 'Colostomy', 'Ileostomy - Stoma', 'Rectal Prolapse', 'Intestinal Polyposis', 'Lymphoma', 'Endometriosis', 'Intestinal Volvulus']}, 'descriptionModule': {'briefSummary': 'The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.\n\nHypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who underwent a laparoscopic or open Low Anterior resection with the creation of an anastomosis using the ColonRing in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient was \\> 18 years old at time of procedure\n2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™\n3. Patient treated in routine clinical practice\n4. Patient underwent his/her first follow-up visit within two months post-surgery\n\nExclusion Criteria:\n\nNo exclusion criteria have been defined for this data collection.'}, 'identificationModule': {'nctId': 'NCT01880918', 'briefTitle': 'A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing', 'organization': {'class': 'INDUSTRY', 'fullName': 'novoGI'}, 'officialTitle': 'Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417', 'orgStudyIdInfo': {'id': 'RETROPRESS, CLPR-43-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ColonRing', 'description': 'The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32701', 'city': 'Atlamonte Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr. Matthew Albert, MD', 'role': 'CONTACT', 'phone': '407-303-5191'}, {'name': 'Leslee Cunnion', 'role': 'CONTACT', 'email': 'Leslee.Cunnion@flhosp.org', 'phone': '407-303-5191'}, {'name': 'Dr. Matthew Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Hospital, Center for Colon & Rectal Surgery'}, {'city': 'Port Charlotte', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr. Domingo E. Galliano Jr., MD', 'role': 'CONTACT', 'email': 'office@gallianosurgery.com', 'phone': '941-625-3411'}, {'name': 'Kathleen Lueck', 'role': 'CONTACT'}, {'name': 'Dr. Domingo E. Galiano Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '18308 Murdock Circle, Suite 108', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr. Jose Dominguez, MD', 'role': 'CONTACT', 'phone': '417-875-3211'}, {'name': 'Kami Oster', 'role': 'CONTACT', 'email': 'Kami.Oster@coxhealth.com', 'phone': '417- 875-3211'}, {'name': 'Dr. Jose Dominguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CoxHealth Hospital, Colorectal Department', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'novoGI', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}