Microdosing ICG for Serial Colonic Perfusion Study During Surgery

February 3, 2024 updated by: Shanglei Liu
using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized dosing of 7.5mg or 0.75mg of ICG injection during surgery for bowel perfusion assessment using new imaging equipment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego
        • Contact:
          • Shanglei Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • all patient undergoing intestinal resection surgery

Exclusion Criteria:

  • pregnancy, renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: regular dose ICG
Active Comparator: micro dose icg
Other: micro dosing of ICG
smaller dose of injection of ICG. All devices used are FDA approved in clinical use.
Other Names:
  • small dose of injection if icg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ability to assess perfusion
Time Frame: up to 30 days post operatively
likert scale evaluation survey performed by surgeon
up to 30 days post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanglei Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

February 3, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 311249-00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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