Intraoperative Ureter InjuryPhase 2NCT04636567
Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery
A Phase 2 study testing Nerindocianine for injection in people with Intraoperative Ureter Injury, run by Li-Cor, Inc. at 2 sites in United States.
Trial summary
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Ureter Injury
- What is being tested?
- Nerindocianine for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2021to Dec 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to the initiation of study procedures.
- At least 18 years of age.
- Consent to undergo minimally invasive, lower pelvic surgery.
Who cannot join
- Unwilling or unable to provide informed consent.
- Unwilling or unable to comply with the requirements of the protocol.
- Females who are pregnant, lactating, or planning a pregnancy throughout the study.
- Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery.
- Have known allergies to D-mannitol and/or citric acid.
- Participation in another clinical trial involving a drug in the past 12 weeks.
- Any other condition that, in the investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy of the investigational product, or determined not a safe candidate for surgery based on standard of care for current medical condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28204
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).
Read the detailed description
The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.
- Conditions
- Intraoperative Ureter Injury
- Being tested
- Nerindocianine for injection
- Keywords
- contrast agent, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerindocianine for injectionDrug
Also called IRDye 800BK
Procedure: routine minimally invasive abdominopelvic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nerindocianine for injection | Experimental | One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery. Receives: Drug: Nerindocianine for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ureter delineation using a Likert scale to measure ureter visualization
Evaluation of the pelvic ureter under WL and NIR illumination
Measured: Surgical procedure duration, estimated up to 5 hours
Secondary outcomes (2)
Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events
Measured: 30 +/- 5 days
Hourly time point scores concurrence with video review
Three 3-pt Likert scale scores at hourly time points during the procedure.
Measured: Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study startMar 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Clinical program has been suspended for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Ureter InjuryStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li-Cor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanna Da Silva Southwich, M.D., Principal investigator, Cleveland Clinic FloridaJubilee Brown, M.D., Principal investigator, Carolinas Medical Center / Levine Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636567
- Sponsor's protocol ID
- LICOR-10417-04
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT04636567
- Acronym / sponsor ID
- LICOR-10417-04
- Conditions
- Intraoperative Ureter Injury
- Keywords
- contrast agent, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical program has been suspended for business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Li-Cor, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Nov 2020 (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.
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).
Detailed description
The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerindocianine for injection | Experimental | Drug: Nerindocianine for injectionOne Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent prior to the initiation of study procedures.
- At least 18 years of age.
- Consent to undergo minimally invasive, lower pelvic surgery.
Key exclusion criteria (7 listed)
- Unwilling or unable to provide informed consent.
- Unwilling or unable to comply with the requirements of the protocol.
- Females who are pregnant, lactating, or planning a pregnancy throughout the study.
- Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery.
- Have known allergies to D-mannitol and/or citric acid.
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 |
|---|---|---|
| Nerindocianine for injectionAlso: IRDye 800BKProcedure: routine minimally invasive abdominopelvic surgery. | Drug | Nerindocianine for injection |
Primary outcome
Evaluation of ureter delineation using a Likert scale to measure ureter visualization
Time frame: Surgical procedure duration, estimated up to 5 hours
Evaluation of the pelvic ureter under WL and NIR illumination
2 secondary outcomes
Treatment-Emergent Adverse Events
Time frame: 30 +/- 5 days
Hourly time point scores concurrence with video review
Time frame: Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available.
Related trials for Intraoperative Ureter Injury
Active, not recruitingPhase 1
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
Ureter Injury
Not yet recruitingPhase 4
Assessing the Efficacy of Indocyanine Green for Ureter Identification During Robot-Assisted Surgery in Advanced-Stage Endometriosis
Indocyanine Green (ICG), Robotic Surgical Procedure
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.
Giovanna Da Silva Southwich, M.D. principal investigator
Cleveland Clinic Florida
Jubilee Brown, M.D. principal investigator
Carolinas Medical Center / Levine Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nerindocianine for injection in people with Intraoperative Ureter Injury, run by Li-Cor, Inc. at 2 sites 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of ureter delineation using a Likert scale to measure ureter visualization (time frame: Surgical procedure duration, estimated up to 5 hours). 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 2 Jul 2021.