CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Cryoablation for the treatment of uterine fibroidsprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00731341
NCT00731341N/ACompleted
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Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies

Boston Scientific Corporation·interventional·Posted Aug 11, 2008·Updated Jul 19, 2021

In Brief

A clinical study evaluating Cryoablation for the treatment of uterine fibroids for Uterine Fibroids and 2 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed Summary

The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based cryoablation needles

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids, Leiomyoma, Menorrhagia
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2008
Enrollment StartJul 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.9 years ago

Interventions

Cryoablation for the treatment of uterine fibroidsprocedure

Needle will be inserted into the fibroid via the cervix through a hysteroscope channel. Gas is circulated through the sealed needle to form an iceball at the tip. After insertion, the needle will be cooled to a temperature of below -100°C to freeze the tissue of the fibroid.