NCT04633486

Brief Summary

Intestinal transplantation is associated with high numbers of ejection events. A close endoscopic controll of the intestinal graft is possible. Sasaki et al. presented 2002 an endoscopic score using zoom-endoscopes for early detection of rejection events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

7.6 years

First QC Date

November 6, 2020

Last Update Submit

November 12, 2020

Conditions

Intestinal Graft Dysfunction

Keywords

endoscopic monitoring, intestinal transplantation

Outcome Measures

Primary Outcomes (1)

  • Rate of congruent findings of zoom-endoscopy and pathological examinations

    Reliability of zoom-endoscopy and pathological examinations

    12 months

Interventions

zoom-endoscopyDIAGNOSTIC_TEST

Endoscopic monitoring of intestinal transplant recipients is done with zoom-endoscopes for exact diagnostic of intestinal mucosa.

Also known as: ZVE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intestinal transplant reciepients since 2005

You may qualify if:

  • intestinal transplant recipients

You may not qualify if:

  • younger age (\< 16)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 18, 2020

Study Start

April 1, 2012

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

DE(1)