Status:
TERMINATED
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Lead Sponsor:
Novadaq Technologies ULC, now a part of Stryker
Conditions:
Rectal Cancer
Rectosigmoid Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 per...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT02205307
Start Date
January 1 2015
End Date
May 1 2017
Last Update
June 24 2020
Active Locations (24)
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1
John Muir Medical Center, Concord Campus
Concord, California, United States
2
Kaiser Permanente
Los Angeles, California, United States
3
University of California, Irvine
Orange, California, United States
4
University of California, San Francisco
San Francisco, California, United States