Fluorescent Evaluation of Colorectal Anastamoses
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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
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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 | Phase |
---|---|---|
Rectal Neoplasms Colon Neoplasms Diverticulitis | Device: Indocyanine Green Device: The SPY® Intraoperative Imaging System | Not Applicable |

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 |

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

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

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
United States, New York | |
Maimonides Medical Center | |
Brooklyn, New York, United States, 11219 |
Principal Investigator: | Danny Sherwinter, MD | Maimonides Medical Center |
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 |