Laparoscopic Tactile Imaging in Urogynecologic Surgery

Completed

Conditions studied: Pelvic Floor Disorders

In brief

During laparoscopic surgery, video camera becomes a surgeon's eyes since the surgeon uses image from the video camera positioned inside the patient's body to perform the procedure. The greatest limitation is the impairment or complete lack of tactile sensation normally used to assist in surgical dissection and decision making. The Investigator proposes to develop a tactile sensing system, Laparoscopic Tactile Imager (LTI), to be used in urogynecological laparoscopic surgery for tactile imaging and tissue characterization (elasticity, structure, boundaries, blood vessel detection) which will be imposed on the video image at area of interest in real time.

Key facts

Study ID

NCT03164850

Run by

Advanced Tactile Imaging, Inc.

People needed

5

Starts

2016-12-09

Expected to finish

2017-04-28

Last updated by the study team

2018-09-19

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stage 2 or greater pelvic organ prolapse;
• Scheduled pelvic floor surgery.

You may not qualify if…

• Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
• Ongoing or prior radiation therapy for abdominal or pelvic cancer;
• Recent (less than four months) pelvic surgery;
• Surgically absent rectum or bladder;
• Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
• Severe abdominal or pelvic adhesions preventing access to pertinent anatomy;
• Known or suspected bleeding disorder.

Where it is running

• Princeton Urogynecology — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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