ThermaChoice III Under Local Sedation in the Office Setting

Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420264

Enrollment

Registered

2007-01-11

Start date

2005-11-30

Completion date

2009-05-31

Last updated

2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Uterine Bleeding

Brief 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.

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.

Interventions

DEVICEUterine Ablation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Heavy uterine bleeding

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

Design outcomes

Primary

Measure	Time frame
Tolerability of Uterine Ablation in the office setting	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026