Perfusion; ComplicationsNCT06254833
Microdosing ICG for Serial Colonic Perfusion Study During Surgery
A study testing micro dosing of ICG in people with Perfusion; Complications, run by Shanglei Liu at 1 site in United States.
Trial summary
using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Perfusion; Complications
- What is being tested?
- micro dosing of ICG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patient undergoing intestinal resection surgery
Who cannot join
- pregnancy, renal insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC San Diego
La Jolla, California, 92093
Shanglei Liu
About this study
using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery
Read the detailed description
Randomized dosing of 7.5mg or 0.75mg of ICG injection during surgery for bowel perfusion assessment using new imaging equipment
- Conditions
- Perfusion; Complications
- Being tested
- micro dosing of ICG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro dosing of ICGOther
Also called small dose of injection if icg
smaller dose of injection of ICG. All devices used are FDA approved in clinical use.
| Study group | Role | What they receive |
|---|---|---|
| regular dose ICG | No intervention | Not described |
| micro dose icg | Active comparator | Not described Receives: Other: micro dosing of ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
ability to assess perfusion
likert scale evaluation survey performed by surgeon
Measured: up to 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Nov 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanglei Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shanglei Liu, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254833
- Sponsor's protocol ID
- 311249-00001
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microdosing ICG for Serial Colonic Perfusion Study During Surgery
- ClinicalTrials.gov ID
- NCT06254833
- Acronym / sponsor ID
- 311249-00001
- Conditions
- Perfusion; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanglei LiuUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery
Detailed description
Randomized dosing of 7.5mg or 0.75mg of ICG injection during surgery for bowel perfusion assessment using new imaging equipment
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regular dose ICG | No intervention | – |
| micro dose icg | Active comparator | Other: micro dosing of ICG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patient undergoing intestinal resection surgery
Key exclusion criteria (1 listed)
- pregnancy, renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro dosing of ICGAlso: small dose of injection if icgsmaller dose of injection of ICG. All devices used are FDA approved in clinical use. | Other | micro dose icg |
Primary outcome
ability to assess perfusion
Time frame: up to 30 days post operatively
likert scale evaluation survey performed by surgeon
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro dosing of ICG in people with Perfusion; Complications, run by Shanglei Liu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanglei Liu ((858)249-1837, jtt005@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability to assess perfusion (time frame: up to 30 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.