Clinical trial · Interventional
Fluorescent Evaluation of Colorectal Anastamoses
The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Neoplasms | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Diverticulitis | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Device | — | UNRESOLVED |
| The SPY® Intraoperative Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indocyanine Green
- description
- 1ml of intravenous ICG and imaging transanally using the Spyscope system
- interventionNames
- Device: Indocyanine Green
- Device: The SPY® Intraoperative Imaging System
Primary outcomes (1)
- measure
- Evaluate the Vascular Supply of the Bowel Intra-operatively and Correlate This With Postoperative Complications Identified During Their Hospital Stay at One Week and One Month Postoperatively.
- timeFrame
- 30 days
- description
- Intra-operative evaluation of bowel perfusion. Participants will be followed for the duration of hospital stay and then at 1 week and 1 month postoperatively to identify postoperative complications.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available