Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06268951
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom severity due to abdominal wall endometriosis following ablation.', 'timeFrame': 'Baseline and intermittently over 24 months', 'description': 'Using the Endometriosis Health Profile - 30 survey, the impact of ablation on endometriosis-related symptoms will be quantified over time. A numerical rating scale will be used to quantify pain at the site of treated abdominal wall endometriosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal Wall endometriosis'], 'conditions': ['Endometriosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis.', 'detailedDescription': 'The purpose of this study is to characterize the recovery and symptom relief following cryoablation of abdominal wall endometriosis. Patients undergoing clinically indicated ablation of abdominal wall endometriosis will receive an endometriosis-specific symptom survey (Endometriosis Health Profile - 30) prior to ablation and then at 3-, 6-, 12-, and 24-months following treatment. A 2 question survey related to pain at the treatment site will also be administered prior to ablation and then at 1-, 7-, and 30-days after ablation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with endometriosis of the abdomen wall.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing ablation for abdominal wall endometriosis.\n\nExclusion Criteria:\n\n* Decline to participate in research.'}, 'identificationModule': {'nctId': 'NCT06268951', 'briefTitle': 'Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis', 'orgStudyIdInfo': {'id': '23-005485'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Thomas Atwell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas D. Atwell', 'investigatorAffiliation': 'Mayo Clinic'}}}}