Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-27 @ 9:17 PM
Study NCT ID:
NCT04151433
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Endometrioma Surgery
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AMH levels 3 months postoperatively', 'timeFrame': '3 months postoperatively', 'description': 'To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis Ovary', 'Endometrioma']}, 'referencesModule': {'references': [{'pmid': '40048474', 'type': 'DERIVED', 'citation': 'Bafort C, Lie Fong S, Fieuws S, Geysenbergh B, Nisolle M, Squifflet JL, Tebache L, Wyns C, Meuleman C, Tomassetti C. Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. PLoS One. 2025 Mar 6;20(3):e0315709. doi: 10.1371/journal.pone.0315709. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.\n\nThe 2 conservatives techniques used are:\n\n1. The combined technique\n2. CO2 laser vaporization only\n\nOvarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.\n\nInclusion Criteria:\n\n* Age: 18 - 40 years (both inclusive)\n* Unilateral endometriotic cysts with a mean diameter of \\>=2.5cm and ≤8 cm, measured in 3 dimensions.\n* Presence of a contralateral endometrioma of ≤ 2cm is allowed\n* Complaining of infertility and/or pain\n* BMI ≤35\n* Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery\n\nExclusion Criteria:\n\n* Incomplete surgery for the pelvis\n* Contra-indication for the use of contraception (combined or Progesteron only)\n* Use of GnRH analogues preoperatively and in the first 3 months postoperatively\n* (History of) hysterectomy\n* Prior unilateral oophorectomy\n* Pituitary/hypothalamic disorders\n* Suspected malignancy\n* Contralateral endometrioma of \\>2 cm\n* AMH \\<0.7 preoperatively\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04151433', 'acronym': 'BLAST', 'briefTitle': 'Conservative Endometrioma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only', 'orgStudyIdInfo': {'id': 'S62899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The combined technique', 'description': 'First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.', 'interventionNames': ['Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CO2 laser vaporization only', 'description': 'CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.', 'interventionNames': ['Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).']}], 'interventions': [{'name': 'Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).', 'type': 'PROCEDURE', 'description': 'cf. different arms', 'armGroupLabels': ['CO2 laser vaporization only', 'The combined technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Brecht Geysenbergh, MD', 'role': 'CONTACT'}, {'name': 'Brecht Geysenbergh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GZA Sint-Augustinus', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laurence Beausaert', 'role': 'CONTACT'}, {'name': 'Jean-Luc Squifflet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christine Wyns, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cliniques universitaires Saint-LUC (UCL)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Celine Bafort, MD', 'role': 'CONTACT', 'email': 'celine.bafort@uzleuven.be'}, {'name': 'Carla Tomassetti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Celine Bafort, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UZLeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marie Timmermans, Msc', 'role': 'CONTACT'}, {'name': 'Michelle Nisolle, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Linda Tebache, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHR La Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Carla Tomassetti, MD, PhD', 'role': 'CONTACT', 'email': 'carla.tomassetti@uzleuven.be', 'phone': '+3216340825'}, {'name': 'Celine Bafort, MD', 'role': 'CONTACT', 'email': 'celine.bafort@uzleuven.be', 'phone': '+3216340088'}], 'overallOfficials': [{'name': 'Carla Tomassetti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leuven University Fertility Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'GZA Ziekenhuizen Campus Sint-Augustinus', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Régional de la Citadelle', 'class': 'OTHER'}, {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}