Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-30 @ 1:50 PM
Study NCT ID:
NCT07032506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}, {'id': 'C562565', 'term': 'Uterine Anomalies'}, {'id': 'D000093665', 'term': 'Septate Uterus'}], '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'}, {'id': 'D000093662', 'term': 'Uterine Duplication Anomalies'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-06-14', 'studyFirstSubmitQcDate': '2025-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of intrauterine adhesion formation following hysteroscopic septoplasty', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Intraoperative complications', 'timeFrame': '12 weeks'}, {'measure': 'Number of participants with postoperative complications', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects completing postop intervention-hormone use', 'timeFrame': '12 weeks'}, {'measure': 'Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit', 'timeFrame': '12 weeks'}, {'measure': 'Long Term Reproductive Outcome', 'timeFrame': '3 years', 'description': 'Number of subjects achieving pregnancy'}, {'measure': 'Surgeon assessment of intervention modality', 'timeFrame': '12 weeks', 'description': 'Surgeon assessment of whether intrauterine adhesions were prevented'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intrauterine foley balloon catheter stent', 'uterine malformations', 'uterine septums', 'hysteroscopic septoplasty'], 'conditions': ['Intrauterine Adhesion']}, 'descriptionModule': {'briefSummary': 'The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.', 'detailedDescription': "This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.\n\nPatients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:\n\nSurgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and above\n* Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process\n* Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent\n* History of prior uterine septum resection\n* History of prior transmural uterine surgery\n* Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions\n* Individuals in whom complete septum resection is unable to be performed as a single procedure'}, 'identificationModule': {'nctId': 'NCT07032506', 'briefTitle': 'Intrauterine Stent Placement Following Hysteroscopic Septum Resection', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection', 'orgStudyIdInfo': {'id': '24-04027291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter', 'description': 'Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.', 'interventionNames': ['Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter', 'Drug: Hormonal Therapy Agent', 'Drug: Oral antibiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter', 'description': 'No placement of an inflated intrauterine pediatric foley catheter', 'interventionNames': ['Procedure: No Catheter placement', 'Drug: Hormonal Therapy Agent']}], 'interventions': [{'name': 'Intraoperative placement of an inflated intrauterine pediatric foley catheter', 'type': 'PROCEDURE', 'description': 'Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.', 'armGroupLabels': ['Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter']}, {'name': 'No Catheter placement', 'type': 'PROCEDURE', 'description': 'No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon', 'armGroupLabels': ['Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter']}, {'name': 'Hormonal Therapy Agent', 'type': 'DRUG', 'description': '2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily)', 'armGroupLabels': ['Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter', 'Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter']}, {'name': 'Oral antibiotics', 'type': 'DRUG', 'description': '100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place', 'armGroupLabels': ['Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205-0000', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'contacts': [{'name': 'Christopher Moutos, MD', 'role': 'CONTACT', 'email': 'res2011@med.cornell.edu', 'phone': '(501) 534-3764'}, {'name': 'Christopher Moutos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arkansas Fertility & Gynecology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Rodriq Stubbs, NP', 'role': 'CONTACT', 'email': 'res2011@med.conrell.edu'}, {'name': 'Glenn Schattman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Mindy Christianson, MD', 'role': 'CONTACT', 'email': 'christm12@ccf.org', 'phone': '(216) 672-1427'}, {'name': 'Christianson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Rodriq Stubbs, NP, MSN', 'role': 'CONTACT', 'email': 'res2011@med.cornell.edu', 'phone': '646-962-3276'}, {'name': 'Sarah Cambria', 'role': 'CONTACT', 'email': 'sac7011@med.cornell.edu', 'phone': '646-962-2961'}], 'overallOfficials': [{'name': 'Glenn Schattman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}