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Fluorescent Evaluation of Colorectal Anastamoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01424293
Recruitment Status : Unknown
Verified August 2015 by Danny A Sherwinter, Maimonides Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2011
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Bowel removal is indicated for various types of colon and rectal disease, including colon cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others.

Following removal of the diseased segment of bowel your surgeon will reconnect the two healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an extremely dangerous situation.

The cause of leakage has many causes and is not well understood, but appears to be at least in part due to not having enough blood going to the bowel. There is currently no way to evaluate the blood supply to the bowel.

The purpose of this study is to utilize a special camera to evaluate the blood supply of the bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing the occurrence of leaks


Condition or disease Intervention/treatment
Rectal Neoplasms Colon Neoplasms Diverticulitis Device: Indocyanine Green Device: The SPY® Intraoperative Imaging System

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion
Study Start Date : May 2010
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Indocyanine Green
1ml of intravenous ICG and imaging transanally using the Spyscope system
Device: Indocyanine Green
1ml of intravenous ICG and imaging transanally using the Spyscope system
Device: The SPY® Intraoperative Imaging System


Outcome Measures

Primary Outcome Measures :
  1. Evaluate the vascular supply to bowel anastomoses [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days and then in the clinic at one week and one month postoperatively ]
    Perioperative evaluation bowel perfusion


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for this study must meet ALL of the following inclusion criteria:

    • Subject is willing and able to provide an informed consent
    • Subject is willing and able to comply with the study procedures
    • Subject speaks English and is able to understand the study procedures
    • A pregnancy test for women of childbearing potential prior to surgery
    • Subject is scheduled for laparoscopic low anterior resection

Exclusion Criteria:

  • Candidates for this study who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:

    • Subject has uremia, serum creatinine >2.5 mg/dl
    • Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
    • Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
    • 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
    • Subject is actively participating in another drug, biologic and/or device protocol
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424293


Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Danny Sherwinter, MD Maimonides Medical Center
More Information

Responsible Party: Danny A Sherwinter, Attending Physician, Surgery, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01424293     History of Changes
Other Study ID Numbers: 1004va09
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Danny A Sherwinter, Maimonides Medical Center:
Rectal Cancer
Colon Cancer
Diverticulitis
Anastamosis
colectomy
low anterior resection

Additional relevant MeSH terms:
Neoplasms
Diverticulitis
Rectal Neoplasms
Colonic Neoplasms
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Rectal Diseases
Colonic Diseases