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

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.