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RECRUITING
NCT07334964
NA

Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method

Sponsor: Centre Hospitalier Régional d'Orléans

View on ClinicalTrials.gov

Summary

This study aims to assess the feasibility, safety, and accuracy of a robotic arm-assisted carpal tunnel injection in comparison with the conventional ultrasound-guided method, prior to conducting a larger-scale study. The use of a robotic arm to maintain the ultrasound probe in position could provide valuable assistance to the physician. The procedure would no longer require the involvement of a third person in addition to the physician. To date, no study has compared these two approaches.

Official title: Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-11-25

Completion Date

2027-02-25

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

PROCEDURE

Carpal tunnel injection

Ultrasound localization will be performed by the physician. He will then perform the injection under ultrasound guidance. In Group A, maintenance of the ultrasound probe during the injection will be performed by the physician assisted by a nurse. In Group B, maintenance of the ultrasound probe during the injection will be performed by the robotic arm. All other aspects of the procedure will be carried out according to usual standards (localization, aseptic technique, injection, etc…). The procedure will be timed from the initial positioning (first contact of the ultrasound probe with the wrist) to the end of the injection (needle withdrawal). Maintenance of participant blinding during the injection: a drape will be placed between the physician and the participant; the robot will be activated in both groups, the participant will wear anti noise headphones, and a nurse will be present in both groups.

Locations (1)

CHU Orléans

Orléans, France