Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-26 @ 11:39 PM
Study NCT ID:
NCT00493493
Status:
UNKNOWN
Last Update Posted:
2007-06-28
First Post:
2007-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003475', 'term': 'Curettage'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-06-27', 'studyFirstSubmitDate': '2007-06-27', 'studyFirstSubmitQcDate': '2007-06-27', 'lastUpdatePostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound failure, time lost from work or school, analgesic requirements, recurrence rates', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'infection rates, wound care requirements', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cymetra'], 'conditions': ['Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': 'Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.', 'detailedDescription': 'In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with pilonidal diseas'}, 'identificationModule': {'nctId': 'NCT00493493', 'briefTitle': 'Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease', 'organization': {'class': 'INDIV', 'fullName': 'Matino, James, M.D.'}, 'officialTitle': 'Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease', 'orgStudyIdInfo': {'id': 'Pilonidal/Cymetra'}}, 'armsInterventionsModule': {'interventions': [{'name': 'surgery (Pore Excision, Curettage, and Injection of Cymetra)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'St Francis Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'centralContacts': [{'name': 'James J Matino, MD', 'role': 'CONTACT', 'email': 'jimanderin@yahoo.com', 'phone': '860-249-8595'}], 'overallOfficials': [{'name': 'James J Matino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical Group,PC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matino, James, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'LifeCell', 'class': 'INDUSTRY'}]}}}