Clinical trial · Interventional
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectosigmoid Cancer | Malignant Rectosigmoid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PINPOINT | Device | — | UNRESOLVED |
| SPY Elite | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PINPOINT or SPY Elite
- description
- 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
- interventionNames
- Device: PINPOINT
- Device: SPY Elite
- type
- NO_INTERVENTION
- label
- STANDARD
- description
- A low anterior resection will be performed according to the surgeon's standard practice
Primary outcomes (1)
- measure
- Anastomotic Leak Rate
- timeFrame
- Day 0 to Week 8 (+/- 2 weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007. PMID 33872284