Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-01 @ 3:43 PM
Study NCT ID:
NCT06894732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-01-25', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical dilation rate (e.g. %)', 'timeFrame': '30'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induced Abortion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the two surgical methods of surgical rotation abortion and surgical negative pressure uterine aspiration with the termination of pregnancy. which one can better protect female fertility; To understand the impact of both surgical approaches on the long-term prognosis of patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age: 20-40 years old, planning to terminate pregnancy; 2) Menopause time≤ 56 days (8 weeks); 3) Ultrasound examination showed early pregnancy in utero, and the average diameter of the fetal sac was 1-3cm; 4) According to the requirements of clinical operation standards, the preoperative examination, laboratory results and surgical indicators are normal 5) The subject was conscious, had good compliance, agreed to participate in the trial, and voluntarily signed the informed consent form\n\nExclusion Criteria:\n\n* 1\\) According to the requirements of clinical practice, there are contraindications to induced abortion; 2) The number of previous induced abortions ≥2 times; 3) Diseases affecting uterine cavity morphology such as uterine malformations and uterine fibroids; 4) History of uterine surgery: such as submucosal myomectomy history, mediastinal resection history, uterine adhesion-separation history; 5) Unable to sign the informed consent; 6) Other conditions that the investigator considers inappropriate to participate in this clinical study.'}, 'identificationModule': {'nctId': 'NCT06894732', 'briefTitle': 'To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion', 'orgStudyIdInfo': {'id': 'ChiCTR2400089857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotary induced abortion', 'interventionNames': ['Procedure: Rotary induced abortion']}], 'interventions': [{'name': 'Rotary induced abortion', 'type': 'PROCEDURE', 'description': 'Rotary induced abortion under ultrasonic monitoring was performed with intravenous anesthesia.', 'armGroupLabels': ['Rotary induced abortion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'xinyan Liu Liuxinyan', 'role': 'CONTACT', 'email': 'liuxymeng@163.com', 'phone': '+86 186 0000 8013'}], 'facility': 'Peking Union Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'xinyan Liu Liuxinyan', 'role': 'CONTACT', 'email': 'liuxymeng@163.com', 'phone': '+86 186 0000 8013'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}