Rectal CancerPhase 1PILLAR IINCT01560377
Perfusion Assessment in Laparoscopic Left Anterior Resection
A Phase 1 study testing PINPOINT Endoscopic Fluorescence Imaging System in people with Rectal Cancer and Colon Cancer, run by Novadaq Technologies ULC, now a part of Stryker at 11 sites in United States.
Trial summary
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Colon Cancer, Crohn's Disease
- What is being tested?
- PINPOINT Endoscopic Fluorescence Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2012to Nov 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge)
- A negative pregnancy test for women of childbearing potential prior to surgery
Who cannot join
- Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Subject is a pregnant or lactating female
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Maimonides Medical Center
Brooklyn, New York, 11219
University Hospital Case Medical Center
Cleveland, Ohio, 44106
University of Southern California
Los Angeles, California, 90089
Ochsner Medical Center
New Orleans, Louisiana, 70121
Beth Israel Medical Center
New York, New York, 10003
Weill Cornell Medical College
New York, New York, 10021
University of California, Irvine
Orange, California, 92868
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Diego
San Diego, California, 92093
University of California San Francisco
San Francisco, California, 94115
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: Open Label Clinical Study to Demonstrate the Utility of Intra-operative Perfusion Assessment Using NIR Fluorescence Angiography With the PINPOINT® Endoscopic Fluorescence Imaging System and to Assess the Impact of PINPOINT on the Surgical Decision Making Process and on Surgical Outcomes in Laparoscopic Left Anterior Resection Procedures
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
Read the detailed description
Colectomy is a surgical procedure in which a part or all of the colon is removed. It is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted bowel.
This study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by NIR fluorescence angiography in colectomy. The initial phase (Phase I) consisted of a number of small investigative studies that have now been completed. Upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (Phase III). Information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp, Procidentia, Diverticulitis
- Being tested
- PINPOINT Endoscopic Fluorescence Imaging System
- Keywords
- Laparoscopic low anterior colon resection, Laparoscopic left colectomy, Colectomy, Rectal cancer, Colon cancer, Crohn's Disease, Polyp, Procidentia, Diverticulitis
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms, Crohn Disease, Polyps, Prolapse, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINPOINT Endoscopic Fluorescence Imaging SystemDevice
The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| Subjects Imaged with PINPOINT | Experimental | Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. Receives: Device: PINPOINT Endoscopic Fluorescence Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
PINPOINT System Utility in Left Colectomy Surgery
To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
Measured: Day of Operation - Day 1
Secondary outcomes (1)
Safety of the PINPOINT System
To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.
Measured: Through hospital discharge or at 30 days post procedure, whichever is later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectal CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novadaq Technologies ULC, now a part of Stryker
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Stamos, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560377
- Sponsor's protocol ID
- Version 1
- Acronym
- PILLAR II
- Status last verified
- Nov 2018
- First submitted
- 19 Mar 2012
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Clinical Study to Demonstrate the Utility of Intra-operative Perfusion Assessment Using NIR Fluorescence Angiography With the PINPOINT® Endoscopic Fluorescence Imaging System and to Assess the Impact of PINPOINT on the Surgical Decision Making Process and on Surgical Outcomes in Laparoscopic Left Anterior Resection Procedures
- ClinicalTrials.gov ID
- NCT01560377
- Acronym / sponsor ID
- PILLAR II / Version 1
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp, Procidentia, Diverticulitis
- Keywords
- Laparoscopic low anterior colon resection, Laparoscopic left colectomy, Colectomy, Rectal cancer, Colon cancer, Crohn's Disease, Polyp, Procidentia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Novadaq Technologies ULC, now a part of StrykerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
Detailed description
Colectomy is a surgical procedure in which a part or all of the colon is removed. It is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted bowel.
This study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by NIR fluorescence angiography in colectomy. The initial phase (Phase I) consisted of a number of small investigative studies that have now been completed. Upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (Phase III). Information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Imaged with PINPOINT | Experimental | Device: PINPOINT Endoscopic Fluorescence Imaging SystemColonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge)
- A negative pregnancy test for women of childbearing potential prior to surgery
Key exclusion criteria (3 listed)
- Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Subject is a pregnant or lactating female
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 |
|---|---|---|
| PINPOINT Endoscopic Fluorescence Imaging SystemThe PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery | Device | Subjects Imaged with PINPOINT |
Primary outcome
PINPOINT System Utility in Left Colectomy Surgery
Time frame: Day of Operation - Day 1
To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
1 secondary outcome
Safety of the PINPOINT System
Time frame: Through hospital discharge or at 30 days post procedure, whichever is later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael J Stamos, MD principal investigator
University of California, Irvine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PINPOINT Endoscopic Fluorescence Imaging System in people with Rectal Cancer and Colon Cancer, run by Novadaq Technologies ULC, now a part of Stryker at 11 sites 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 3 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PINPOINT System Utility in Left Colectomy Surgery (time frame: Day of Operation - Day 1). 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 11 Dec 2018.