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A Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps

NCT01509313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2013-09-16

No results posted yet for this study

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 designed miniature operating instruments are passed to remove the polyp(s). At present the most commonly used instruments use an electrical cutting edge. However, a new instrument using a mechanical cutting edge has come to market. In patients having a general anaesthesia the mechanical cutting instrument has been shown to be easier to learn, more effective at completely removing polyps and quicker. However, the instrument is slightly larger, which could potentially cause more discomfort and prolong the procedure in the outpatient setting. Therefore, the investigators want to compare the electrical and mechanical instruments for speed, completeness of polyp removal and patient acceptability.

Conditions

  • Endometrial Polyps

Interventions

DEVICE

hysteroscopic morcellator (TruClear)

It can be used to treat uterine pathology with a mechanical cutting edge

DEVICE

Bipolar Electrical resectoscope (Versapoint)

It can be used to treat uterine pathology with an electrical cutting edge

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Birmingham Women's NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Thomas J Clark, MBChB · Birmingham Womens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509313 on ClinicalTrials.gov