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

Inclusion Criteria:

- 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 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.