- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848575
A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy (Culdo)
September 13, 2013 updated by: University of Arkansas
The culdoscopic approach will allow for equal or better visualization of female pelvic structures
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.
Time Frame: 02/2010
|
02/2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
02/2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander Burnett, MD, UAMS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
September 16, 2013
Last Update Submitted That Met QC Criteria
September 13, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 99075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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