A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
NCT ID: NCT00848575
Last Updated: 2013-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2009-02-28
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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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.
Flexible Endoscope
Interventions
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Flexible Endoscope
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
Yes
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Alexander Burnett, MD
Role: PRINCIPAL_INVESTIGATOR
UAMS
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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99075
Identifier Type: -
Identifier Source: org_study_id