Acute CholecystitisPhase 1NIRF-C AcuteNCT02070627
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study
A Phase 1 study testing Indocyanine Green (ICG) and Near Infrared Fluorescence Cholangiography (NIRF-C) in people with Acute Cholecystitis and Acute Cholangitis, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Cholecystitis, Acute Cholangitis
- What is being tested?
- Indocyanine Green (ICG) and Near Infrared Fluorescence Cholangiography (NIRF-C)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2014
- Phase
- Phase 1
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Planned laparoscopic cholecystectomy
Who cannot join
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.
- Conditions
- Acute Cholecystitis, Acute Cholangitis
- Being tested
- Indocyanine Green (ICG), Near Infrared Fluorescence Cholangiography (NIRF-C)
- Keywords
- acute cholecystitis, acute cholangitis, cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG)Drug
60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.
Near Infrared Fluorescence Cholangiography (NIRF-C)Device
Also called Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)
Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.
| Study group | Role | What they receive |
|---|---|---|
| NIRF-C and IOC | Experimental | Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography. Receives: Drug: Indocyanine Green (ICG); Device: Near Infrared Fluorescence Cholangiography (NIRF-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to use of indocyanine green (ICG)
Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.
Measured: Injection to 2 wk follow-up
Anatomic identification with NIRF-C and IOC
Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.
Measured: Intraoperative
Procedure time
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Principal investigator, Narula, Vimal K, MD, Ohio State University
- Investigators
- Vimal K Narula, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070627
- Sponsor's protocol ID
- 2011H0239S
- Acronym
- NIRF-C Acute
- Status last verified
- Oct 2014
- First submitted
- 21 Feb 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
- ClinicalTrials.gov ID
- NCT02070627
- Acronym / sponsor ID
- NIRF-C Acute / 2011H0239S
- Conditions
- Acute Cholecystitis, Acute Cholangitis
- Keywords
- acute cholecystitis, acute cholangitis, cholecystectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- 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.
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRF-C and IOC | Experimental | Drug: Indocyanine Green (ICG), Device: Near Infrared Fluorescence Cholangiography (NIRF-C)Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-89
- Planned laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Lactating
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 |
|---|---|---|
| Indocyanine Green (ICG)60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging. | Drug | NIRF-C and IOC |
| Near Infrared Fluorescence Cholangiography (NIRF-C)Also: Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy. | Device | NIRF-C and IOC |
Primary outcome
Adverse events related to use of indocyanine green (ICG)
Time frame: Injection to 2 wk follow-up
Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.
Anatomic identification with NIRF-C and IOC
Time frame: Intraoperative
Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.
Procedure time
Time frame: Intraoperative
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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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.
Vimal K Narula, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine Green (ICG) and Near Infrared Fluorescence Cholangiography (NIRF-C) in people with Acute Cholecystitis and Acute Cholangitis, run by Ohio State University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 3 Nov 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to use of indocyanine green (ICG) (time frame: Injection to 2 wk follow-up). The study lists 3 primary outcomes in all. 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 3 Nov 2014.