NCT03164850

Laparoscopic Tactile Imaging in Urogynecologic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Advanced Tactile Imaging, Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Floor Disorders

Interventions

Type	Name	Description
DEVICE	Laparoscopic Tactile Imaging	Provides Tactile feedback during laparoscopic surgery

Timeline

• Start date: 2016-12-09
• Primary completion: 2017-04-05
• Completion: 2017-04-28
• First posted: 2017-05-24
• Last updated: 2018-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study