Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 4, 2022

Primary Completion Date

January 17, 2025

Study Completion Date

March 29, 2025

Conditions
Rotator Cuff TendinitisSyndrome Rotator CuffTendinopathyTendinoses, Rotator CuffRotator Cuff Injuries
Interventions
DEVICE

MD-Shoulder Collagen Medical Device

"Only one experimental group is scheduled by the Investigation Plan to be treated with 2-mL volume ultrasound-guided infiltrations of MD-Shoulder Collagen Medical Device (GUNA, Milan-Italy).~Subjects will be treated with number one ultrasound-guided infiltration at the time of enrollment, 2 weeks after enrollment, and 4 weeks after enrollment.~Intra-articular infiltrations will be performed with 5cc syringes and 22-gauge needles.~MD-Shoulder Collagen Medical Device will be infiltrated within the scapulohumeral joint under conditions of complete asepsis."

Trial Locations (1)

20122

Gaetano Pini CTO, Milan

All Listed Sponsors
lead

Guna S.p.a

INDUSTRY