NCT06254833

Brief Summary

using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

January 11, 2024

Last Update Submit

February 3, 2024

Conditions

Perfusion; Complications

Outcome Measures

Primary Outcomes (1)

  • ability to assess perfusion

    likert scale evaluation survey performed by surgeon

    up to 30 days post operatively

Study Arms (2)

regular dose ICG

NO INTERVENTION

micro dose icg

ACTIVE COMPARATOR
Other: micro dosing of ICG

Interventions

micro dosing of ICGOTHER

smaller dose of injection of ICG. All devices used are FDA approved in clinical use.

Also known as: small dose of injection if icg
micro dose icg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patient undergoing intestinal resection surgery

You may not qualify if:

  • pregnancy, renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

RECRUITING

Central Study Contacts

Shanglei Liu

CONTACT

(858)249-1837jtt005@health.ucsd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2024

First Posted

February 12, 2024

Study Start

November 1, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)