Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT05337605
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)', 'timeFrame': '1 to 4 years', 'description': 'Patient reported outcome by means of a questionnaire (yes/no, specify)'}], 'secondaryOutcomes': [{'measure': 'Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)', 'timeFrame': '1 to 4 years', 'description': 'Patient reported outcome by means of a questionnaire (yes/no, specify)'}, {'measure': 'Recurrence interval (time to recurrence of endometrial polyp)', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire (when did blood loss occur / when was polyp identified)'}, {'measure': 'Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire'}, {'measure': 'Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire (yes/no, specify)'}, {'measure': 'Rate of occurrence of new polyps (+ cause, treatment)', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire (yes/no, specify)'}, {'measure': 'Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)'}, {'measure': 'General satisfaction score in regard to initial treatment', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)'}, {'measure': 'Rate of need for additional treatment', 'timeFrame': '1 to 4years', 'description': 'Patient reported outcome by means of a questionnaire (yes/no, specify)'}, {'measure': 'Chance of pregnancy after treatment', 'timeFrame': '1 to 4 years', 'description': 'Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Polyp']}, 'referencesModule': {'references': [{'pmid': '38492506', 'type': 'DERIVED', 'citation': 'Van Geyte M, de Frenne A, Weyers B, Weyers S, van Vliet H, Hamerlynck T, van Wessel S. Manually driven versus motor driven hysteroscopic tissue removal system for polypectomy: Long-term results. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:270-274. doi: 10.1016/j.ejogrb.2024.03.013. Epub 2024 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'In this study, a comparison is made between two types of polyp resection methods (hand driven and motor driven morcellation). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps.\n\nThe aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.', 'detailedDescription': '* Rationale: several techniques for hysteroscopic removal of intrauterine polyps exist today. Hysteroscopic morcellation is an effective, fast, and safe method for this. However, the differences between two different systems of hysteroscopic morcellation, motor-driven (Truclear incisor mini device) and hand-driven (Resectr 9fr) morcellation, are still unclear. The REMOvE9 study, in which women with a polyp were randomized between both techniques, is currently investigating the differences in short-term effectiveness between the two techniques.\n* Research question/goal: To investigate the long-term results of the effectiveness of a hysteroscopic morcellation of intrauterine polyps. The two systems are compared with each other.\n* Study design: This is a prospective cohort study. The patients previously participated in a randomized controlled trial (REMOvE9) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.\n* Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in the REMOvE9 study.\n* Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women treated for endometrial polyps in earlier study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participation in earlier study\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05337605', 'briefTitle': 'Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results', 'orgStudyIdInfo': {'id': 'BC-11626 BC-11627 BC-11628'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hand driven tissue removal system', 'description': 'Endometrial polyp removed by hysteroscopic hand-driven tissue removal system in a previous study.'}, {'label': 'Motor driven tissue removal system', 'description': 'Endometrial polyp removed by hysteroscopic motor-driven tissue removal system in a previous study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Tjalina Hamerlynck, Md, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}