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A Study to Compare the Effectiveness of Two Different Outpatient Endometrial Ablation Techniques Used for Heavy Periods

NCT01124357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2010-05-17

No results posted yet for this study

Summary

STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM endometrial ablation?

Conditions

  • Menorrhagia

Interventions

DEVICE

NovaSure

Bipolar radio-frequency energy ablation of the endometrium by thermal therapy under impedance control. The bipolar current generated by the device produces a tapered depth of ablation with shallower ablation in the cornual regions / lower uterine segment and a deeper ablation in the mid-body of the uterus..

DEVICE

thermachoice

ThermachoiceTM III thermal balloon ablation

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY

  • Birmingham Women's NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Justin Mr Clark, MD MRCOG · Birmingham Women's NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-10-31
Completion
2008-10-31

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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 NCT01124357 on ClinicalTrials.gov