Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-01 @ 12:01 AM
Study NCT ID:
NCT00755651
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2008-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-18', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discomfort', 'timeFrame': 'End of procedure'}], 'secondaryOutcomes': [{'measure': 'Procedure time, biopsy adequacy', 'timeFrame': 'End of procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menorrhagia', 'Uterine fibroids', 'Endometrial polyps', 'Endometrial cancer'], 'conditions': ['Abnormal Uterine Bleeding']}, 'referencesModule': {'references': [{'pmid': '15958000', 'type': 'RESULT', 'citation': "Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. Outpatient hysteroscopy: traditional versus the 'no-touch' technique. BJOG. 2005 Jul;112(7):963-7. doi: 10.1111/j.1471-0528.2005.00425.x."}]}, 'descriptionModule': {'briefSummary': 'The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.', 'detailedDescription': 'We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication to carry out diagnostic hysteroscopy\n* Agrees and is suitable for outpatient/office hysteroscopy\n\nExclusion Criteria:\n\n* Failed outpatient/office hysteroscopy'}, 'identificationModule': {'nctId': 'NCT00755651', 'briefTitle': 'Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Royal Free Hampstead NHS Trust'}, 'officialTitle': 'Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy', 'orgStudyIdInfo': {'id': 'REC 6056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H Pipelle', 'description': 'Endometrial sample obtained using the H Pipelle', 'interventionNames': ['Procedure: Endometrial biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pipelle', 'description': 'Endometrial sample obtained with standard Pipelle', 'interventionNames': ['Procedure: Endometrial biopsy']}], 'interventions': [{'name': 'Endometrial biopsy', 'type': 'PROCEDURE', 'otherNames': ['Pipelle', 'H Pipelle'], 'description': 'Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy', 'armGroupLabels': ['H Pipelle', 'Pipelle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Adam Magos, BSc MD FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Free Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Free Hampstead NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Adam Magos BSc MB BS MD FRCOG, Consultant Gynaecologist', 'oldOrganization': 'Royal Free Hospital'}}}}