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NCT05346380 · ClinicalTrials.gov registry record · Phase 1

Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery Download

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target

NCT05346380: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT05346380 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT05346380, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target

Study Summary

This will be a prospective, (NSR), single-center feasibility study of the Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy and pulmonary segmentectomy. The aims of the study are: 1\. To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System to: i. Characterize gastric conduit perfusion during esophagectomy and, ii. Identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.

Primary Outcome

Fluorescent intensity, visualization of the intersegmental plane with NIR imaging, image quality will all be ranked by the surgeon as "below standard, average, or good" compared to the standard of care as they identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.

Interventions

  • DRUG Indocyanine green
  • DEVICE Olympus VE2 NIR Imaging System

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2020-10-29
Est. Completion 2025-06-03
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT05346380 record still lists

NCT05346380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 2 interventions - of which Indocyanine green is the first listed.

NCT05346380 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05346380 about?

NCT05346380 is a clinical study titled "Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery Download". This will be a prospective, (NSR), single-center feasibility study of the Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy and pulmonary segmentectomy. The aims of the study are: 1\. To utilize NIR intraoperative imaging with the Olympus VE2 NIR I...

What is the current status of trial NCT05346380?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2020-10-29. Estimated completion is 2025-06-03.

What interventions are being tested in trial NCT05346380?

The interventions under investigation include: Indocyanine green (DRUG), Olympus VE2 NIR Imaging System (DEVICE).

Who is sponsoring clinical trial NCT05346380?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05346380's enrollment target sits among peer trials

38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05346380, the US trial registry maintained by the National Library of Medicine. NCT05346380 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.