Pelvic Floor DisordersLTINCT03164850
Laparoscopic Tactile Imaging in Urogynecologic Surgery
An observational study of Pelvic Floor Disorders, run by Advanced Tactile Imaging, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Laparoscopic Tactile Imaging
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2016to 28 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Stage 2 or greater pelvic organ prolapse;
- Scheduled pelvic floor surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Princeton Urogynecology
Princeton, New Jersey, 08540
About this study
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.
Read the 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
- Being tested
- Laparoscopic Tactile Imaging
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Tactile ImagingDevice
Provides Tactile feedback during laparoscopic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Soft tissue elasticity measurement (Pa)
LTI allows acquisition of stress+strain data to calculate direct tissue elasticity in Pa.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start9 Dec 2016
- Primary completion5 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Tactile Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Urogynecology
- Responsible party
- Sponsor
- Investigators
- Heather van Raalte, Principal investigator, Princeton Urogynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164850
- Sponsor's protocol ID
- LTI07
- Acronym
- LTI
- Status last verified
- May 2017
- First submitted
- 16 Mar 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Scientific Publications of the study results
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Tactile Imaging in Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT03164850
- Acronym / sponsor ID
- LTI / LTI07
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Advanced Tactile Imaging, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Princeton Urogynecology
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Stage 2 or greater pelvic organ prolapse;
- Scheduled pelvic floor surgery.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Tactile ImagingProvides Tactile feedback during laparoscopic surgery | Device | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: Yes. Scientific Publications of the study results
Related trials for Pelvic Floor Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather van Raalte principal investigator
Princeton Urogynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Advanced Tactile Imaging, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging Performance (resolution in mm) (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.