- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164850
Laparoscopic Tactile Imaging in Urogynecologic Surgery (LTI)
September 17, 2018 updated by: Advanced Tactile Imaging, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08540
- Princeton Urogynecology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
Inclusion Criteria:
- Stage 2 or greater pelvic organ prolapse;
- Scheduled pelvic floor surgery.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging Performance (resolution in mm)
Time Frame: 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.
|
up to 24 weeks
|
Soft tissue elasticity measurement (Pa)
Time Frame: up to 24 weeks
|
LTI allows acquisition of stress+strain data to calculate direct tissue elasticity in Pa.
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather van Raalte, Princeton Urogynecology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 9, 2016
Primary Completion (ACTUAL)
April 5, 2017
Study Completion (ACTUAL)
April 28, 2017
Study Registration Dates
First Submitted
March 16, 2017
First Submitted That Met QC Criteria
May 22, 2017
First Posted (ACTUAL)
May 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 19, 2018
Last Update Submitted That Met QC Criteria
September 17, 2018
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTI07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Scientific Publications of the study results
IPD Sharing Time Frame
6 months after closing study will be available in Scientific Publications
IPD Sharing Access Criteria
Scientific Publications
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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