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

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ClinicalTrials.gov Identifier: NCT02205307
Recruitment Status : Terminated (Slow recruitment)
First Posted : July 31, 2014
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novadaq Technologies Inc.

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 perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

Condition or disease Intervention/treatment Phase
Rectal Cancer Rectosigmoid Cancer Device: PINPOINT Device: SPY Elite Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Study Start Date : January 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: PINPOINT or SPY Elite
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
Device: PINPOINT
Device: SPY Elite
No Intervention: STANDARD
A low anterior resection will be performed according to the surgeon's standard practice



Primary Outcome Measures :
  1. Anastomotic Leak Rate [ Time Frame: Day 0 to Week 8 ]

Secondary Outcome Measures :
  1. Evaluate the ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure [ Time Frame: Day 0 to Week 8 ]
  2. Rate of postoperative abscess requiring surgical management [ Time Frame: Day 0 to Week 8 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02205307


  Show 24 Study Locations
Sponsors and Collaborators
Novadaq Technologies Inc.
Investigators
Principal Investigator: Michael J Stamos, MD University of California, Irvine
Principal Investigator: Steven Wexner, MD Cleveland Clinic Florida

Responsible Party: Novadaq Technologies Inc.
ClinicalTrials.gov Identifier: NCT02205307     History of Changes
Other Study ID Numbers: PP PLR 03
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Novadaq Technologies Inc.:
Rectal cancer
Rectal neoplasm
Colorectal surgery
Anastomosis

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases