Intestinal TransplantNCT06718400
Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation
A study testing Sentinel Skin Flap in people with Intestinal Transplant, run by The Cleveland Clinic.
Trial summary
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing and monitoring rejection in intestinal transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Transplant
- What is being tested?
- Sentinel Skin Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of an intestinal transplant.
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
Who cannot join
- Patient does not have a patent ulnar artery in either forearm or a negative Allen's test.
- Patient is not willing to return to the Institution for all clinical follow-up for 12 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.
About this study
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing and monitoring rejection in intestinal transplantation
Read the detailed description
Intestinal transplantation is the current treatment option for patients with irreversible intestinal failure that has not responded to other methods of treatment. Whilst the majority of patients that have an intestinal transplant will obtain good graft function over many years, some patients suffer from reduced function of their new intestine following transplantation that can progress to the transplant failing completely.
Acute rejection may be the most common cause of transplant failure. Currently, there is not an effective way of monitoring the intestine that can detect rejection before irreversible damage occurs. If there is a more sensitive way of continuously monitoring the intestine transplant for rejection then issues could be earlier detected and early treatment could prevent permanent damage to the transplant.
The reason for this study is to assess a new technique that has been developed to detect early rejection in intestinal transplantation. The name of this technique is called a 'sentinel skin flap' and involves transplanting a patch of forearm skin from the donor at the same time as the intestine
- Conditions
- Intestinal Transplant
- Being tested
- Sentinel Skin Flap
- Keywords
- Transplant, Sentinel Skin Flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Skin FlapProcedure or surgery
Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Skin Flap | Experimental | Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor Receives: Procedure: Sentinel Skin Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of histological rejection in the skin flap and the transplanted solid organ
To establish if a sentinel skin flap acts as a marker of rejection of the transplanted organ.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study startOct 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Departure of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal TransplantStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Vaidya, The Cleveland Clinic
- Investigators
- Anil Vaidya, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718400
- Sponsor's protocol ID
- 21-882
- Status last verified
- Dec 2024
- First submitted
- 9 May 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation
- ClinicalTrials.gov ID
- NCT06718400
- Acronym / sponsor ID
- 21-882
- Conditions
- Intestinal Transplant
- Keywords
- Transplant, Sentinel Skin Flap
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Departure of PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Dec 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.
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing and monitoring rejection in intestinal transplantation
Detailed description
Intestinal transplantation is the current treatment option for patients with irreversible intestinal failure that has not responded to other methods of treatment. Whilst the majority of patients that have an intestinal transplant will obtain good graft function over many years, some patients suffer from reduced function of their new intestine following transplantation that can progress to the transplant failing completely.
Acute rejection may be the most common cause of transplant failure. Currently, there is not an effective way of monitoring the intestine that can detect rejection before irreversible damage occurs. If there is a more sensitive way of continuously monitoring the intestine transplant for rejection then issues could be earlier detected and early treatment could prevent permanent damage to the transplant.
The reason for this study is to assess a new technique that has been developed to detect early rejection in intestinal transplantation. The name of this technique is called a 'sentinel skin flap' and involves transplanting a patch of forearm skin from the donor at the same time as the intestine
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor
| Arm | Type | Receives |
|---|---|---|
| Sentinel Skin Flap | Experimental | Procedure: Sentinel Skin FlapWilling participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipient of an intestinal transplant.
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
Key exclusion criteria (3 listed)
- Patient does not have a patent ulnar artery in either forearm or a negative Allen's test.
- Patient is not willing to return to the Institution for all clinical follow-up for 12 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the 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 |
|---|---|---|
| Sentinel Skin FlapWilling participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor | Procedure or surgery | Sentinel Skin Flap |
Primary outcome
Correlation of histological rejection in the skin flap and the transplanted solid organ
Time frame: 12 months
To establish if a sentinel skin flap acts as a marker of rejection of the transplanted organ.
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 5 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Intestinal Transplant
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
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.
Anil Vaidya, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Skin Flap in people with Intestinal Transplant, run by The Cleveland Clinic.
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 3 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 5 Dec 2024. 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.
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?
Correlation of histological rejection in the skin flap and the transplanted solid organ (time frame: 12 months). 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 5 Dec 2024.