Clinical trial • Phase IV • Musculoskeletal

Clinical trial in Achilles tendinopathy

Phase IV trial for Achilles tendinopathy. 276 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Achilles tendinopathy
Trial Stage
Phase IV

Key dates

Initial CTIS Submission Date
24-12-2025
First CTIS Authorization Date
16-03-2026

Trial design

Phase IV trial across 8 sites in Netherlands.

Target Sample Size
276

Eligibility

Recruits 276 No vulnerable populations selected (isVulnerablePopulationSelected: false); consent/assent handling not specified in the record..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false); consent/assent handling not specified in the record.

Recruitment

Planned Sample Size
276
Recruitment Window Months
44

Geography

Total Number Of Sites
8
Total Number Of Participants
276

Netherlands

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
10
Number Of Sites
8
Number Of Participants
276

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Orthopedics and Sports Medicine
Principal Investigator Name
Robert-Jan de Vos
Principal Investigator Email
r.devos@erasmusmc.nl
Contact Person Name
Robert-Jan de Vos
Contact Person Email
r.devos@erasmusmc.nl
Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
Sports Medicine
Principal Investigator Name
Johannes Zwerver
Principal Investigator Email
jzwerver@zgv.nl
Contact Person Name
Johannes Zwerver
Contact Person Email
jzwerver@zgv.nl
Site Name
Bergman Clinics Nederland B.V.
Department Name
Sports Medicine
Principal Investigator Name
Maarten Moen
Principal Investigator Email
m.moen@bergmanclinics.nl
Contact Person Name
Maarten Moen
Contact Person Email
m.moen@bergmanclinics.nl
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Sports Medicine
Principal Investigator Name
Peter van Veldhoven
Principal Investigator Email
p.van.veldhoven@haaglandenmc.nl
Contact Person Name
Peter van Veldhoven
Site Name
UMCU
Department Name
Sports Medicine
Principal Investigator Name
Fred Hartgens
Principal Investigator Email
l.m.g.hartgens@umcutrecht.nl
Contact Person Name
Fred Hartgens
Contact Person Email
l.m.g.hartgens@umcutrecht.nl
Site Name
Isala Klinieken Stichting
Department Name
Sports Medicine
Principal Investigator Name
Sietske van Berkel
Principal Investigator Email
s.v.berkel@isala.nl
Contact Person Name
Sietske van Berkel
Contact Person Email
s.v.berkel@isala.nl
Site Name
Amsterdam UMC Stichting
Department Name
Orthopedics and Sports Medicine
Principal Investigator Name
Johannes Tol
Principal Investigator Email
j.l.tol@amsterdamumc.nl
Contact Person Name
Johannes Tol
Contact Person Email
j.l.tol@amsterdamumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) - alternate address

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

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