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A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

This study is currently recruiting participants.
Verified March 2013 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00848575
First received: February 19, 2009
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

The culdoscopic approach will allow for equal or better visualization of female pelvic structures


Condition Intervention
Diagnostic or Therapeutic Laparoscopy
 Device: Flexible Endoscope

Study Type: Observational
Official Title: A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared. [ Time Frame: 02/2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications related to the procedures will be recorded and, if possible, attributed to one of the two techniques. If feasible, a comparison will be made between complications attributable to each approach. [ Time Frame: 02/2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2009
Groups/Cohorts Assigned Interventions
Group 1 - Device
The principal Investigator and sub-investigators of this study will identify potential participants that attend the gynecologic oncology or gynecology clinics of UAMS. These subjects will have been scheduled for diagnostic or therapeutic laparoscopy. Based on the Inclusion Criteria and Exclusion Criteria of this study, women who are eligible for the study will be approached to participate.
 Device: Flexible Endoscope

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Participants will be selected from among women attending the gynecologic clinics or gynecologic oncology clinic of UAMS. Subjects from all races and ethnicities may participate. No children (aged <18 years) are to be enrolled.

Criteria

Inclusion Criteria:

  • Female
  • Ages 18 to 70 years old
  • Ability to understand and give informed consent
  • Scheduled for diagnostic or therapeutic laparoscopy for a clinical indication
  • Presence of a uterus and at least one ovary at the initiation of the procedure

Exclusion Criteria:

  • Documented culdesac mass
  • Inability to tolerate anesthesia
  • Documentation of positive urine pregnancy test
  • History of prior pelvic radiation
  • Scheduled for emergency laparoscopy
  • Any other medical or psychiatric condition that, in the opinion of the investigative team, will interfere with the ability of the participant to safely complete the study
  • History of significant non-compliance with previous therapy or unwillingness to return for follow up visits
  • Prior hysterectomy and/or bilateral salpingo-oophorectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848575

Contacts
Contact: Cynthia Walton 501-686-8274 waltoncynthial@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Alexander Burnett, MD            
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Alexander Burnett, MD UAMS
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00848575     History of Changes
Other Study ID Numbers: 99075
Study First Received: February 19, 2009
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013