Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 3:53 PM
Study NCT ID:
NCT01014494
Status:
UNKNOWN
Last Update Posted:
2010-12-09
First Post:
2009-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaprev in Digital Flexor Tendon Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013708', 'term': 'Tendon Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.', 'timeFrame': '26 weeks post surgery'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair', 'timeFrame': '26 weeks post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tendon Injuries']}, 'descriptionModule': {'briefSummary': 'This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.\n\nExclusion Criteria:\n\n* Subjects with additional complicated injuries\n* Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair\n* Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.\n* Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.\n* Subjects with conditions which may delay healing.\n* Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.\n* Females who are pregnant'}, 'identificationModule': {'nctId': 'NCT01014494', 'briefTitle': 'Adaprev in Digital Flexor Tendon Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renovo'}, 'officialTitle': 'A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand', 'orgStudyIdInfo': {'id': 'RN1008-0083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active - Adaprev', 'description': 'Adaprev (Class III medical device)', 'interventionNames': ['Device: Adaprev']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'No different treatment to normal'}], 'interventions': [{'name': 'Adaprev', 'type': 'DEVICE', 'otherNames': ['Product contains mannose-6-phosphate'], 'description': 'Class III Medical Device', 'armGroupLabels': ['Active - Adaprev']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': "Addenbrooke's Hospital, Cambridge", 'state': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Patrick Gillespie', 'role': 'CONTACT', 'email': 'Patrick.gillespie@addenbrookes.nhs.uk', 'phone': '01223 274632'}], 'facility': 'Mr P Gillespie', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'state': 'Greater Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Miss V C Lees', 'role': 'CONTACT', 'phone': '+44 (0) 161 291 6648'}, {'name': 'Vivien C Lees', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of South Manchester NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'The Lister Hospital, Stevenage', 'state': 'Hertfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mr Schreuder', 'role': 'CONTACT', 'email': 'Fred.schreuder@nhs.net', 'phone': '01438 781162'}], 'facility': 'Mr F Schreuder', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}, {'zip': 'E1 1BB', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Kamal El-Ali', 'role': 'CONTACT', 'email': 'Kamal.El-Ali@bartsandthelondon.nhs.uk', 'phone': '07986 693062'}, {'name': 'Raj Ragoowansi', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kamal El Ali', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royal London Hospital, Barts and The London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Donald Dewar', 'role': 'CONTACT', 'phone': '020 7794 0500', 'phoneExt': '31302'}, {'name': 'Donald Dewar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mr Chakrabarty', 'role': 'CONTACT', 'email': 'khchakrabarty@yahoo.com', 'phone': '020 8237 2777', 'phoneExt': '55490'}, {'name': 'Beryl De Souza', 'role': 'CONTACT', 'email': 'bds@dr.com'}, {'name': 'Kaushik Chakrabarty', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Beryl De Souza', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chelsea & Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury District Hospital', 'state': 'Salisbury', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Roderick Dunn', 'role': 'CONTACT', 'email': 'sue.dubber@salisbury.nhs.uk', 'phone': '01722 336262', 'phoneExt': '3555'}], 'facility': 'Mr R Dunn'}, {'zip': 'SO16 6YD', 'city': 'Southampton General Hospital', 'state': 'Southampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David Warwick', 'role': 'CONTACT', 'email': 'davidjwarwick@btinternet.com', 'phone': '023 8079 5212'}, {'name': 'Elaine Hayward', 'role': 'CONTACT', 'email': 'elaine.hayward@suht.swest.nhs.uk', 'phone': '02380 794 989'}], 'facility': 'Mr D Warwick'}, {'zip': 'SA12 7BR', 'city': 'Swansea', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mr D Boyce', 'role': 'CONTACT', 'phone': '+44 (0) 1792 703722'}, {'name': 'Mr D Boyce', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abertawe Bro Morgannwg University Nhs Trust', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'John Hutchison, MBBS PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Renovo Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Harriet Wibberley, Senior Clinical Project Manager', 'oldOrganization': 'Renovo'}}}}