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A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy (Culdo)

This study has been terminated.
(Low enrollment)
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: February 19, 2009
Last updated: September 13, 2013
Last verified: September 2013
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 ]

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 ]

Enrollment: 2
Study Start Date: February 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00848575

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

Responsible Party: University of Arkansas Identifier: NCT00848575     History of Changes
Other Study ID Numbers: 99075
Study First Received: February 19, 2009
Last Updated: September 13, 2013 processed this record on August 22, 2017