Determination of the "Tissue Transit Time" (TTT)
1 other identifier
observational
119
2 countries
9
Brief Summary
Determination of Tissue Transit Time (TTT) as a parameter with high prognostic value to predict the functional course of the differential renal function and the development of the differential renal function after pyeloplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedStudy Start
First participant enrolled
November 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2021
CompletedMay 9, 2022
November 1, 2020
3.6 years
October 11, 2017
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity
Estimation of Sensitivity and Specificity of a delayed tissue transit time as a diagnostic factor concerning worsening of the differential renal function in patients with congenital ureteropelvic junction obstruction
3 to 6 months
Secondary Outcomes (3)
Examination of ultrasound findings
3 to 6 months
Examination of renal drainage
3 to 6 months
Examination of initial differential renal function
3 to 6 months
Interventions
Determination of Tissue Transit Time as a prognostic and diagnostic factor
Eligibility Criteria
Term born infants \<= 3 months of age with a unilateral, insolated hydronephrosis \>= grade III (SFU)
You may qualify if:
- unilateral, isolated hydronephrosis \>= grade III (SFU)
- age \<= 3 months
You may not qualify if:
- associated malformation of the urogenital tract
- global kidney insufficiency proven by creatinine examination
- prematurity
- no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Kinderchirurgische Klinik
Augsburg, 86156, Germany
Klinik für Kinderchirurgie und Kinderurologie
Bremen, 28205, Germany
Klinik für Kinderchirurgie und Kinderurologie
Dortmund, 44137, Germany
Kinderchirurgische Klinik
Karlsruhe, 76133, Germany
Zentrum für Kinder- und Jugendurologie
Mannheim, 68167, Germany
Klinik für Kinderchirurgie
Marburg, 35043, Germany
Cnopf'sche Kinderklinik
Nuremberg, 90419, Germany
Klinik für Kinder- und Jugendmedzin
Tübingen, 72076, Germany
Kinderchiurgische Klinik, Luzerner Kantonsspital
Lucerne, 6000, Switzerland
Related Publications (1)
Luithle T, Obermayr F, Dittmann H, Engel C, Etzler A, Kosch F, Menke IT, Schafer M, Schuster T, Younsi N, Fuchs J. Determination of tissue tracer transit of Technetium-99m-mercaptoacetyltriglycine diuretic renography in infants with suspected ureteropelvic junction obstruction - A multicenter prospective observational study. J Pediatr Urol. 2023 Dec;19(6):780.e1-780.e7. doi: 10.1016/j.jpurol.2023.08.029. Epub 2023 Sep 1.
PMID: 37718234DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Luithle, MD
Universtiätsklinikum Tübingen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 17, 2017
Study Start
November 23, 2017
Primary Completion
June 30, 2021
Study Completion
November 24, 2021
Last Updated
May 9, 2022
Record last verified: 2020-11