Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-28 @ 7:19 PM
Study NCT ID:
NCT05475756
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2022-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}, {'id': 'D007246', 'term': 'Infertility'}], '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': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-23', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-07-23', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective rate', 'timeFrame': 'Day 73±12', 'description': 'At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate of adhesions', 'timeFrame': 'Day 73±12', 'description': 'The Presence of adhesions was determined at second-look hysteroscopy after Hysteroscopic adhesiolysis, and the recurrence rate of adhesions (%) = number of adhesion reoccurrence/total number in the group × 100%'}, {'measure': 'Extent of uterine adhesions', 'timeFrame': 'Day 73±12', 'description': 'The degree of uterine adhesions was assessed intraoperatively and at the second-look hysteroscopy with reference to the ESGE (European Society for Gynecological Endoscopy) criteria'}, {'measure': 'Endometrial improvement', 'timeFrame': 'Day -7 to day 1, Day 100±10', 'description': 'Endometrial thickness in millimeter and change values in millimeter by Ultrasonic Diagnostic Equipment Transvaginal Ultrasonic Probe Head at screening and visit 4'}, {'measure': 'Time of menstrual recovery', 'timeFrame': 'Day 73±12', 'description': 'Time to first menstruation after Hysteroscopic adhesiolysis'}, {'measure': 'Duration of Menstrual recovery', 'timeFrame': 'Day 73±12, Day 100±10 , Day 180±30, Day 360±30', 'description': 'Days of menstrual duration'}, {'measure': 'Menstrual blood volume', 'timeFrame': 'Day 73±12, Day 100±10 , Day 180±30, Day 360±30', 'description': 'Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC)'}, {'measure': 'Pregnancy rate after operation 1year', 'timeFrame': 'Day 360±30', 'description': 'Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometrium', 'Adhesion', 'Postoperative adhesion', 'Hysteroscopy', 'Biological Barrier', 'Adhesion prevention', 'Infertility', 'Hysteroscopic Adhesiolysis'], 'conditions': ['Intrauterine Adhesion']}, 'referencesModule': {'references': [{'pmid': '21549641', 'type': 'BACKGROUND', 'citation': "March CM. Management of Asherman's syndrome. Reprod Biomed Online. 2011 Jul;23(1):63-76. doi: 10.1016/j.rbmo.2010.11.018. Epub 2010 Dec 4."}, {'pmid': '18406834', 'type': 'BACKGROUND', 'citation': 'Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.'}, {'pmid': '3371491', 'type': 'BACKGROUND', 'citation': 'The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, mullerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. doi: 10.1016/s0015-0282(16)59942-7. No abstract available.'}, {'pmid': '20014360', 'type': 'BACKGROUND', 'citation': 'Leone FP, Timmerman D, Bourne T, Valentin L, Epstein E, Goldstein SR, Marret H, Parsons AK, Gull B, Istre O, Sepulveda W, Ferrazzi E, Van den Bosch T. Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group. Ultrasound Obstet Gynecol. 2010 Jan;35(1):103-12. doi: 10.1002/uog.7487.'}, {'pmid': '2400752', 'type': 'BACKGROUND', 'citation': "Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x."}, {'pmid': '28603474', 'type': 'BACKGROUND', 'citation': 'AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available.'}, {'pmid': '28723687', 'type': 'RESULT', 'citation': 'Kong D, Zhang L, Xu X, Zhang J, Li Y, Huang X. Small Intestine Submucosa Is a Potential Material for Intrauterine Adhesions Treatment in a Rat Model. Gynecol Obstet Invest. 2018;83(5):499-507. doi: 10.1159/000479086. Epub 2017 Jul 20.'}, {'pmid': '32192600', 'type': 'RESULT', 'citation': 'Zhang X, Qiu J, Ding Y, Sun L, Hua K. Single port laparoscopy combined with vaginal cervicovaginal reconstruction in a patient with congenital atresia of the cervix. Fertil Steril. 2020 Mar;113(3):681-682. doi: 10.1016/j.fertnstert.2019.11.011.'}, {'pmid': '23932377', 'type': 'RESULT', 'citation': 'Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.'}, {'pmid': '20576472', 'type': 'RESULT', 'citation': 'Amer MI, Abd-El-Maeboud KH, Abdelfatah I, Salama FA, Abdallah AS. Human amnion as a temporary biologic barrier after hysteroscopic lysis of severe intrauterine adhesions: pilot study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):605-11. doi: 10.1016/j.jmig.2010.03.019. Epub 2010 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.', 'detailedDescription': 'This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.\n\nThe trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .\n\nSubjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* （1）Age, yr20-40 (including boundary value), Female\n* （2）Normal ovarian reserve function (FSH\\<10U/ml，AMH\\>2ng/ml)\n* （3）Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis\n* （4）Both husband and wife have fertility intention during treatment\n* （5）Accept to treatment and follow-up visits, Sign the ICF\n\nExclusion Criteria:\n\n* （1）Severe systemic diseases, contraindications of surgical and cycle\n* （2）Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs\n* （3）Systemic diseases cause uterine bleeding\n* （4）Allergic to hyaluronic acid or components\n* （5）Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons\n* （6）Insufficient uterine cavity volume after Hysteroscopic adhesiolysis to place Intrauterine Biological Barrier or inject Intrauterine Adhesion Barrier Gel\n* （7）Involved other clinical trial before Hysteroscopic adhesiolysis in 3 months or during the trail\n* （8）Unable to tolerate anesthesia\n* （9）Estrogen medicine was taken within 30 days of Hysteroscopic adhesiolysis\n* （10）Other inadequacy patient assessed by the researchers'}, 'identificationModule': {'nctId': 'NCT05475756', 'briefTitle': 'Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail', 'orgStudyIdInfo': {'id': 'RKM-GPSIS-CTP202201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Material：Small intestinal submucosa Specifications：A、B、C、D、E Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency：one time after the operation Duration：Single-use', 'interventionNames': ['Device: Intrauterine Biological Barrier']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Material: auto-crosslinked HA gel Specifications: 1 ml, 1.25 ml, 1.5 ml, 1.75 ml, 2 ml, 2.25 ml, 2.5 ml, 2.75 ml, 3 ml, 3.25 ml, 3.75 ml, 4 ml, 4.25 ml, 4.5 ml, 5 ml, 6 ml, 8ml Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency：one time after the operation Duration：Single-use', 'interventionNames': ['Device: Intrauterine Adhesion Barrier Gel']}], 'interventions': [{'name': 'Intrauterine Biological Barrier', 'type': 'DEVICE', 'description': 'after Hysteroscopic adhesiolysis，use of Intrauterine Biological Barrier to repair uterine cavity', 'armGroupLabels': ['Experimental Group']}, {'name': 'Intrauterine Adhesion Barrier Gel', 'type': 'DEVICE', 'description': 'after Hysteroscopic adhesiolysis，use of Intrauterine Adhesion Barrier Gel to repair uterine cavity', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Gao', 'role': 'CONTACT'}, {'name': 'Ting Gao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anhui Provincial Hosptial', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhang', 'role': 'CONTACT'}, {'name': 'Qi Zhang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Limin Feng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Zhangzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feifeng Shi', 'role': 'CONTACT'}, {'name': 'Feifeng Shi', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caixia Hong', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhangzhou Municipal Hospital of Fujian Province', 'geoPoint': {'lat': 24.51333, 'lon': 117.65556}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Zhang', 'role': 'CONTACT'}, {'name': 'Hao Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaofeng Zeng', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Guangzhou First people's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shunyu Hou', 'role': 'CONTACT'}, {'name': 'Shunyu Hou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Suzhou Municipal Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Xi’an', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xifeng Xiao', 'role': 'CONTACT'}, {'name': 'Xifeng Xiao', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wanlin Zhang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Limin Feng', 'role': 'CONTACT', 'email': 'Lucyfeng1966@163.com', 'phone': '18911281961'}], 'overallOfficials': [{'name': 'Limin Feng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing, only data collection and filling into paper CRF by each site'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhangzhou Municipal Hospital of Fujian Province', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'Suzhou Municipal Hospital', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Obstetrics and Gynecology', 'investigatorFullName': 'Limin Feng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}