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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

February 19, 2009
March 25, 2013
February 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00848575 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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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Observational
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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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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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
Female
18 Years to 70 Years
Yes
Contact: Cynthia Walton 501-686-8274 waltoncynthial@uams.edu
United States
 
NCT00848575
99075
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Alexander Burnett, MD UAMS
University of Arkansas
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP