Status:
COMPLETED
A Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps
Lead Sponsor:
Birmingham Women's NHS Foundation Trust
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Endometrial Polyps
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief Summary
Outpatient polyp treatment can be performed in a few different ways but generally involves passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through which specifically ...
Detailed Description
The miniaturisation of hysteroscopes and ancillary instrumentation coupled with enhanced visualisation has enabled hysteroscopic surgery to be performed in an outpatient setting without the need for g...
Eligibility Criteria
Inclusion
- Finding of a benign polyp on diagnostic hysteroscopy
- Patient considered able to tolerate outpatient hysteroscopic polypectomy based upon the response to preliminary diagnostic hysteroscopy. NB. all polyps diagnosed at hysteroscopy will be considered feasible to remove in the outpatient setting regardless of size, location or number. Patient factor(s) will be the only exclusion criteria following the diagnosis of benign, uterine polyp(s).
- Need for polypectomy
- Written informed consent
Exclusion
- • Hysteroscopic features suggesting malignant lesion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01509313
Start Date
June 1 2012
End Date
June 1 2013
Last Update
September 16 2013
Active Locations (1)
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1
Birmingham Womens Hospital
Birmingham, West Midlands, United Kingdom, B15 2TG