Laparoscopic Tactile Imaging in Urogynecologic Surgery

NCT03164850 | Completed FDA Device

• 1 other identifier: LTI07
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (2)

• Imaging Performance (resolution in mm)

  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.

  up to 24 weeks

• Soft tissue elasticity measurement (Pa)

  LTI allows acquisition of stress+strain data to calculate direct tissue elasticity in Pa.

  up to 24 weeks

Interventions

Laparoscopic Tactile Imaging DEVICE

Provides Tactile feedback during laparoscopic surgery

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Women scheduled for pelvic floor surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female subjects volunteers, scheduled for a pelvic floor surgery will be considered to be enrolled in the pilot clinical study. Conditions precluding patients from participation are listed in the study exclusion below ( Eligibility Criteria) criteria. No patients will be excluded on the basis of age or race. Women younger the age 21 will not be included due to the very low probability of pelvic floor diseased condition in the age.

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.

Sponsors & Collaborators

• Advanced Tactile Imaging, Inc.: lead
• Princeton Urogynecology: collaborator

Study Sites (1)

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Heather van Raalte

  Princeton Urogynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: May 24, 2017
• Study Start: December 9, 2016
• Primary Completion: April 5, 2017
• Study Completion: April 28, 2017
• Last Updated: September 19, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 6 months after closing study will be available in Scientific Publications
• Access Criteria: Scientific Publications

Locations

US (1)