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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848575
Recruitment Status : Terminated (Low enrollment)
First Posted : February 20, 2009
Last Update Posted : September 16, 2013
Information provided by (Responsible Party):
University of Arkansas

February 19, 2009
February 20, 2009
September 16, 2013
February 2009
July 2013   (Final data collection date for primary outcome measure)
Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared. [ Time Frame: 02/2010 ]
Same as current
Complete list of historical versions of study NCT00848575 on Archive Site
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 ]
Same as current
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A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
The culdoscopic approach will allow for equal or better visualization of female pelvic structures
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Probability Sample
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.
Diagnostic or Therapeutic Laparoscopy
Device: Flexible Endoscope
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.
Intervention: Device: Flexible Endoscope
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Arkansas
University of Arkansas
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Principal Investigator: Alexander Burnett, MD UAMS
University of Arkansas
September 2013