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

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ClinicalTrials.gov Identifier: NCT00848575
Recruitment Status : Terminated (Low enrollment)
First Posted : February 20, 2009
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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

Condition or disease Intervention/treatment
Diagnostic or Therapeutic Laparoscopy Device: Flexible Endoscope

Study Type : Observational
Actual Enrollment : 2 participants
Official Title: A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
Study Start Date : February 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared. [ Time Frame: 02/2010 ]

Secondary Outcome Measures :
  1. 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 ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848575


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

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00848575     History of Changes
Other Study ID Numbers: 99075
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013