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Robotic Subretinal tPA Injection Study

NCT06347107 · Universitaire Ziekenhuizen KU Leuven · Updated 2 Sept 2025

What is being tested
Robotic subretinal tPA injection
For
Subretinal Hemorrhage; Age-Related Macular Degeneration
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 20 people. The full rules are on the registry page.
Where
Belgium
When
Starts or started 21 June 2024, ends 12 Aug 2025. Registered 4 April 2024.
Results
None posted yet.

In the researchers' words

In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following: * The robotic stabilizer (prototype - FAMHP approval received) * 41G subretinal needle (CE marked - used within label) * Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes. As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review.
ClinicalTrials.gov, NCT06347107

Sites

  • UZ LeuvenLeuven, Vlaams-Brabant, Belgium