A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

Diagnostic or Therapeutic Laparoscopy Clinical Trial

— Culdo  

Official title:

A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00848575
• Other study ID #: 99075
• Status: Terminated
• Phase: N/A
• First received: February 19, 2009
• Last updated: September 13, 2013
• Start date: February 2009
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Diagnostic or Therapeutic Laparoscopy

Intervention

Device:
• Flexible Endoscope

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.		02/2010	No
Secondary	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.		02/2010	No