findmyKOL
Clinical trialNCT01998854TerminatedObservational

Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

SponsorGynesonicsEnrollment4LeiomyomaMenorrhagiaUterine FibroidsUterine FibromaUterine Neoplasms
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected. Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France
  • Le Centre Hospitalier Regional Et Universitaire de Tours - Hôpital Bretonneau

    Tours, Cedex, France

  • Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre

    Paris, France

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2013
Primary completion
30 Jun 2014
Completion
31 Jan 2015
Last update posted
11 Mar 2015
Registered enrollment
4
Registry id
NCT01998854

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.