NCT00420264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

January 10, 2007

Last Update Submit

August 13, 2013

Conditions

Heavy Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

  • Tolerability of Uterine Ablation in the office setting

    30 days

Interventions

Uterine AblationDEVICE

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

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Heavy uterine bleeding

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Valley Gynecologists, PC

Grand Rapids, Michigan, 49506, United States

Location

Study Officials

  • Jason B Bennett, MD

    Grand Valley Gynecologists, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

November 1, 2005

Primary Completion

June 1, 2008

Study Completion

May 1, 2009

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

US(1)