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COMPLETED
NCT04670536

The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)

Sponsor: Medicrea International

View on ClinicalTrials.gov

Summary

The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).

Official title: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

77

Start Date

2018-05-17

Completion Date

2024-05-22

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DEVICE

PASS LP implants

Thoraco lumbar arthrodesis

DEVICE

PASS DEGEN

Thoraco lumbar arthrodesis

DEVICE

PASS TULIP PRIME

Thoraco lumbar arthrodesis

Locations (4)

Clinique du Dos Bordeaux - Terrefort

Bruges, France

Clinique des Cèdres

Cornebarrieu, France

CHRU Tours, Hôpital de Bretonneau

Tours, France

Hôpital Pitié-Salpêtrière AP-HP

Paris, Île-de-France Region, France