Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:49 PM
Study NCT ID:
NCT07314632
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study in Laser Treatment of Pilonidal Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical recurrence', 'timeFrame': '2 years post-operatively', 'description': '2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilonidal sinus', 'laser', 'risk factors', 'Recurrence rates'], 'conditions': ['Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus.\n\nThe main question it aims to answer is:\n\n• Is there a clinical recurrence (presence of a fistula in the intergluteal cleft) 2 years after laser treatment of pilonidal sinus? Participants who undergo surgery as part of their regular medical care will answer survey questions about recurrence at 1 and 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will be conducted in two centers that regularly perform laser treatment for pilonidal cysts.\n\nRecruitment will be conducted prospectively upon the patients' arrival at the digestive surgery department.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring laser surgery for pilonidal sinus, of any type (including recurrence after radical cure or laser treatment)\n* Patient able to understand the protocol and having given written informed consent to participate in the study,\n* Patient affiliated to the social security system or entitled to it.\n\nExclusion Criteria:\n\n* Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device\n* Patient already included in a research study\n* Patient under guardianship, conservatorship, or deprived of liberty\n* Patient under an activated future protection mandate\n* Patient under family authorization\n* Patient under judicial protection.'}, 'identificationModule': {'nctId': 'NCT07314632', 'acronym': 'LASPRO', 'briefTitle': 'Prospective Study in Laser Treatment of Pilonidal Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Prospective Study on the Incidence of Recurrence in Laser Treatment of Pilonidal Cysts', 'orgStudyIdInfo': {'id': 'CH25_0098'}, 'secondaryIdInfos': [{'id': '2025-A02356-43', 'type': 'OTHER', 'domain': 'national registration number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients requiring laser surgery for pilonidal sinus', 'description': 'pilonidal sinus of any type (including recurrence after radical cure or laser treatment)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cornebarrieu', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francesco MARTINI, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tristan GREILSAMER, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}], 'centralContacts': [{'name': 'Agnès DORION', 'role': 'CONTACT', 'email': 'agnes.dorion@ght85.fr', 'phone': '0251446380', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Tristan GREILSAMER, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Departemental Vendée'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}