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CompletedNCT00420264Updated Aug 14, 2013

ThermaChoice III Under Local Sedation in the Office Setting

An interventional study of Uterine Ablation in Heavy Uterine Bleeding, sponsored by Female Pelvic Medicine & Urogynecology Institute of Michigan. Completed at 1 site in United States. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-14.

Sponsored by Female Pelvic Medicine & Urogynecology Institute of Michigan · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
30 Years to 60 Years
Sex
Female
01

Study summary

Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.

Read the detailed description

A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.

02

Conditions studied

  • Heavy Uterine Bleeding

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03

In context

Uterine Hemorrhage

156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.

This study's enrollment of 21 is below the median of 96 across 111 interventional studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Female Pelvic Medicine & Urogynecology Institute of Michigan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Heavy uterine bleeding

Exclusion criteria

Exclusion Criteria:

  • Uterine or cervical cancer
  • Unable to tolerate office hysteroscopy
  • Uterine fibroid tumors that distort endometrial cavity
  • Uterine cavity greater than 12 cm
  • Patients with hyperplasia or premalignant changes of the endometrium
  • Active genital or urinary tract infections
  • Intrauterine device
  • Pregnant or want to become pregnant
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Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Interventions

  • DeviceUterine Ablation

    Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation

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What researchers measure

Primary outcomes

  1. Tolerability of Uterine Ablation in the office setting

    Time frame: 30 days

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Study locations

1 site
  • Grand Valley Gynecologists, PC
    Grand Rapids, Michigan 49506, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00420264
Lead sponsor
Female Pelvic Medicine & Urogynecology Institute of Michigan
Collaborators
Ethicon, Inc.
First posted
Jan 11, 2007
Start date
Nov 2005
Primary completion
Jun 2008
Completion
May 2009
Last update
Aug 14, 2013

Study contacts

Jason B Bennett, MD
principal investigator · Grand Valley Gynecologists, PC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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