A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection



Status:Terminated
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/24/2017
Start Date:January 2015
End Date:May 2017

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A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

This is a randomized, controlled, parallel, multicenter study to determine the difference in
post-operative anastomotic leak rate in low anterior resection procedures where colon and
rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical
practice compared to surgical procedures performed according to standard surgical practice
alone.


Inclusion Criteria:

- Be 18 years of age or older.

- Be undergoing open, or minimally invasive LAR for the treatment of a rectal or
rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be
treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must
have been completed ≥6 weeks prior to LAR surgery (Day 0).

- Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from
the anal verge.

- Have a colorectal or coloanal reconstruction with or without reservoir/pouch.

- Subjects who are women of child-bearing potential must not be pregnant or lactating,
must have a negative pregnancy test at Day 0.

- Have signed an approved informed consent form for the study.

- Be willing to comply with the protocol.

Exclusion Criteria:

- Undergoing stapled anastomosis with the use of an experimental or non-FDA approved
stapler.

- Undergoing ileoanal reconstruction, total colectomy or proctocolectomy,
abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple
synchronous colon resections (e.g., LAR and concomitant right colectomy).

- Has received and completed a course of pelvic radiotherapy ≥ 6 months prior to LAR
surgery (Day 0).

- Has previously undergone a left sided colon resection.

- Has previously undergone a rectal resection.

- Has recurrent rectal or rectosigmoid cancer.

- Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended
en bloc operations.

- Has a diagnosis of Stage IV rectal or rectosigmoid cancer with any multifocal
metastases or single site metastasis with tumor size of > 2 cm (Intraoperative
incidental finding or preoperative suspicion of Stage IV cancer with isolated (single
site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in
size, does not exclude the subject).

- Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or
rectosigmoid cancer neoplasms and IBD are excluded.

- Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score
>12.

- Renal dysfunction defined as creatinine ≥ 2.0 mg/dL.

- Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.

- Has, in the Investigator's opinion, any medical condition that makes the subject a
poor candidate for the investigational procedure, or interferes with the
interpretation of study results.

- Is actively participating in another investigational clinical study which, in the
Investigator's or Sponsor's opinion, would interfere in this study.
We found this trial at
24
sites
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Liliana Bordeianou, MD
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Emre Gorgun, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: James Fleshman, MD
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Alyssa Fajardo, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Joel Bauer, MD
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Sowsan Rasheid, MD
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: David Maron, MD
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Bashar Safar, MD
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Baltimore, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cleveland, OH
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Concord, California 94520
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Concord, CA
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Houston, Texas 77030
Principal Investigator: Eric Haas, MD
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Houston, TX
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Jacksonville, Florida 32216
Principal Investigator: Ron Landman, MD
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Las Vegas, Nevada 89109
Principal Investigator: Ovunc Bardakcioglu, MD
Phone: 702-671-6421
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Los Angeles, California 90027
Principal Investigator: Elisabeth McLemore, MD
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New Orleans, Louisiana 70121
Principal Investigator: David Margolin, MD
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New York, New York 10003
Principal Investigator: Joseph Martz, MD
Phone: 214-420-4732
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New York, New York 10021
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Orange, California 92868
Principal Investigator: Alessio Pigazzi, MD
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Orange, CA
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1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
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San Francisco, California 94143
Principal Investigator: Madhulika Varma, MD
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San Francisco, CA
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