Graft FailurePhase 3NCT04685174
Intraoperative NIRS of Transplanted Kidney for Prediction of Acute and Sub-acute Injury
A Phase 3 study testing Invos Model 5100C Cerebral/Somatic Oximeter in people with Graft Failure, run by Tel-Aviv Sourasky Medical Center.
Trial summary
This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Failure
- What is being tested?
- Invos Model 5100C Cerebral/Somatic Oximeter
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Mar 2023
- Phase
- Phase 3
- 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
- Kidney transplant candidates (living/ cadaver donor) at TLVMC who will consent to participate.
Who cannot join
- Patients unable to give consent,
- patients whose surgeries were aborted before transplant,
- patients who were lost to follow up during the first 7 post-transplant days,
- patients who suffered from surgical graft failure (vascular problems or need for re exploration due to bleeding etc.)
- No pregnant patients will participate in this study.
- No minors will participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intraoperative Near Infrared Spectroscopy of Transplanted Kidney for Prediction of Acute and Sub-acute Kidney Injury in Transplanted Patients
This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy.
- Conditions
- Graft Failure
- Being tested
- Invos Model 5100C Cerebral/Somatic Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invos Model 5100C Cerebral/Somatic OximeterDevice
To measure the correlation between post arterial and venous anastomoses (reperfusion) NIRS values of transplanted kidney and post-transplant graft failure as manifested in initiation of renal replacement therapy post transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Failure
Initiation of renal replacement therapy
Measured: 7 days post operative
Graft Failure
Initiation of renal replacement therapy
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft FailureStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685174
- Sponsor's protocol ID
- TASMC-20-OG-0143-20-CTIL
- Status last verified
- Dec 2020
- First submitted
- 9 Nov 2020
- Last updated
- 28 Dec 2020
- Results posted
- 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 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Near Infrared Spectroscopy of Transplanted Kidney for Prediction of Acute and Sub-acute Kidney Injury in Transplanted Patients
- ClinicalTrials.gov ID
- NCT04685174
- Acronym / sponsor ID
- TASMC-20-OG-0143-20-CTIL
- Conditions
- Graft Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 28 Dec 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.
This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant candidates (living/ cadaver donor) at TLVMC who will consent to participate.
Key exclusion criteria (6 listed)
- Patients unable to give consent,
- patients whose surgeries were aborted before transplant,
- patients who were lost to follow up during the first 7 post-transplant days,
- patients who suffered from surgical graft failure (vascular problems or need for re exploration due to bleeding etc.)
- No pregnant patients will participate in this study.
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 |
|---|---|---|
| Invos Model 5100C Cerebral/Somatic OximeterTo measure the correlation between post arterial and venous anastomoses (reperfusion) NIRS values of transplanted kidney and post-transplant graft failure as manifested in initiation of renal replacement therapy post transplant | Device | – |
Primary outcome
Graft Failure
Time frame: 7 days post operative
Initiation of renal replacement therapy
Graft Failure
Time frame: 6 months post operative
Initiation of renal replacement therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Invos Model 5100C Cerebral/Somatic Oximeter in people with Graft Failure, run by Tel-Aviv Sourasky Medical Center.
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 6 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 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Orr Goren, Dr (+972527360330, org@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Failure (time frame: 7 days post operative). The study lists 2 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 28 Dec 2020.