Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 4:45 PM
Study NCT ID:
NCT04884334
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2021-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VAC-Stent Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004939', 'term': 'Esophageal Perforation'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful treatment of the leakage with the VAC-Stent®', 'timeFrame': 'up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Rate of morphological healing of the insufficiency', 'timeFrame': 'approximately 4 weeks after end of treatment'}, {'measure': 'Number of Participants with complications', 'timeFrame': 'approximately 4 weeks after end of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perforation Oesophagus', 'Oesophageal Anastomotic Leak', 'endoscopic vacuum therapy', 'Perforation Colon'], 'conditions': ['Perforation of the Oesophagus', 'Perforation of the Colon']}, 'referencesModule': {'references': [{'pmid': '39083099', 'type': 'DERIVED', 'citation': 'Heiss MM, Lange J, Knievel J, Yohannes A, Hugle U, Dormann AJ, Eisenberger CF. Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study. Langenbecks Arch Surg. 2024 Jul 31;409(1):234. doi: 10.1007/s00423-024-03426-5.'}, {'pmid': '37215348', 'type': 'DERIVED', 'citation': 'Lange J, Knievel J, Wichmann D, Kahler G, Wiedbrauck F, Hellmich T, Kandler M, Bernhardt J, Scholz D, Beyna T, Hausmann J, Wedi E, Ellrichmann M, Hugle U, Dormann AJ, Eisenberger CF, Heiss MM. Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept. Front Surg. 2023 May 5;10:1182094. doi: 10.3389/fsurg.2023.1182094. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.', 'detailedDescription': 'For this registry, quality assurance data will be prospectively collected from all patients who receive the VAC-Stent®. The VAC-Stent® combines a vacuum sponge, which lies intraluminal and conditions the wound, with a covered stent, which seals the sponge from the lumen and thus ensures passage. Due to its design, the new medical device VAC-Stent® offers a solution for the most important problems of the covered stent, the stent migration and the lack of drainage function, as well as for those of the endoluminal vacuum sponge, the blockage of the gastrointestinal lumen and the difficult application. The VAC-Stent® is the technical advancement for all indications of the covered stent and for the indication of the endoluminal vacuum sponge, so that a very good effectiveness with reduced complications can be expected for these clinical situations.\n\nThe VAC-Stent® therefore offers the prospect of an innovative further development in the endoscopic treatment of leaks in the gastrointestinal tract, without any new and unknown risks being associated with it.\n\nThe primary aim of this registry is to collect data on the quality assurance and application of the VAC-Stent® and thus to evaluate the suitability of the VAC-Stent® for sealing leaks in the oesophagus or colon. In addition, the safety and efficacy of the VAC-Stent® will be demonstrated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* treatment with the VAC-Stent®\n\nExclusion Criteria:\n\n\\- accommodation in an institution under court or administrative order'}, 'identificationModule': {'nctId': 'NCT04884334', 'briefTitle': 'VAC-Stent Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Witten/Herdecke'}, 'officialTitle': 'Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment', 'orgStudyIdInfo': {'id': 'VAC-Stent Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VAC-Stent® treatment', 'description': 'spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon', 'interventionNames': ['Device: VAC-Stent®']}], 'interventions': [{'name': 'VAC-Stent®', 'type': 'DEVICE', 'description': 'treatment with the VAC-Stent®', 'armGroupLabels': ['VAC-Stent® treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Sana Klinikum Lichtenberg', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'St. Josef-Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Johanniter Krankenhaus Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Bremerhaven', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Ameos Klinikum Am Bürgerpark', 'geoPoint': {'lat': 53.55357, 'lon': 8.57553}}, {'city': 'Celle', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Allgemeines Krankenhaus Celle', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'zip': '51109', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus M Heiss, Prof Dr', 'role': 'CONTACT', 'email': 'HeissM@kliniken-koeln.de', 'phone': '+4922189073771'}], 'facility': 'Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Uniklinik Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'KRH Klinikum Siloah', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Osnabrück', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Nils Stensen Kliniken, Marienhospital Osnabrück', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Saarbrücken', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Caritas Klinikum Saarbrücken - St. Theresia', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Uniklinik Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Asklepios Paulinen Klinik Wiesbaden', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'centralContacts': [{'name': 'Markus M Heiss, Prof Dr', 'role': 'CONTACT', 'email': 'HeissM@kliniken-koeln.de', 'phone': '+4922189073771'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Markus M. Heiss', 'class': 'OTHER'}, 'collaborators': [{'name': 'VAC Stent GmbH', 'class': 'UNKNOWN'}, {'name': 'Möller Medical GmbH', 'class': 'UNKNOWN'}, {'name': 'MicroTech Europe GmbH', 'class': 'UNKNOWN'}, {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof Dr', 'investigatorFullName': 'Markus M. Heiss', 'investigatorAffiliation': 'University of Witten/Herdecke'}}}}