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Robotic Subretinal tPA Injection Study

NCT06347107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-02

No results posted yet for this study

Summary

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.

Conditions

  • Subretinal Hemorrhage
  • Age-Related Macular Degeneration

Interventions

DEVICE

Robotic subretinal tPA injection

-The insertion of a 41G subretinal needle adjacent to a subretinal hemorrhage using the stabilizing (tremor-reducing) properties of a robotic instrument in order to slowly inject tPA and evaluate whether the needle can be held in place for up tot 3 minutes.

Sponsors & Collaborators

  • DORC Dutch Ophthalmic Research Center International BV

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Peter Stalmans, MD PhD · UZ Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2025-08-12
Completion
2025-08-12

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06347107 on ClinicalTrials.gov