Laparoscopic Tactile Imaging in Urogynecologic Surgery

Completed

• Conditions: Pelvic Floor Disorders

• Registration Number: NCT03164850
• Lead Sponsor: Advanced Tactile Imaging, Inc.

Brief Summary

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.

Detailed Description

For this study, the investigator identified the sacrocolpopexy as the target procedure for the evaluation of LTI. In the cases of sacrocolpopexy, often performed in conjunction with a hysterectomy, one of the most frustrating elements is the lack of tactile feedback at the level of the sacral promontory. The surgeon needs to open up the peritoneum and dissect the underlying tissue to expose the sacral bony structures and ligament without injury to the surrounding bowel, ureter or vascular structures. Sometimes, the sacral promontory is covered with a fat pad which makes it difficult to visualize the promontory and the "safe" space below the aorta and between the iliac arteries/veins is difficult to discern. A difference that is very easy to appreciate with an open procedure where one can easily palpate through the fatty tissues. That step is very critical for the repair and has the greatest potential for catastrophic error without tactile sensation. Because of the reproducibility of the surgical technique and target anatomy for this portion of the procedure, it was thought the sacral promontory dissection to identify and clear the anterior longitudinal ligament would be appropriate surgical procedure to evaluate the use of LTI.

Study Timeline

• Study Start: 2016-12-09
• Study First Submitted: 2017-03-16
• Primary Completion: 2017-04-05
• Study Completion: 2017-04-28
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Imaging Performance (resolution in mm)	up to 24 weeks	The LTI will restore the missing dimension during laparoscopic surgery - the real time 'sense of touch' for tissues and organs of interest. Imaging resolution is a key parameter for the outcome.
Soft tissue elasticity measurement (Pa)	up to 24 weeks	LTI allows acquisition of stress+strain data to calculate direct tissue elasticity in Pa.

Trial Locations

Locations (1)

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States