A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

University of Arkansas

Status: Terminated

Conditions: Diagnostic or Therapeutic Laparoscopy

Treatments: Device: Flexible Endoscope

Study type: Observational

Funder types: Other

Identifiers

NCT00848575

99075

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2 participants in 1 patient group

Group 1 - Device

Description:

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.

Treatment:

Device: Flexible Endoscope