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SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair

NCT00775892 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-08-09

No results posted yet for this study

Summary

A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

DEVICE

SeriACL Device ACL Reconstruction

Long-term Bioresorbable ACL Scaffold

Sponsors & Collaborators

  • Serica Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Hans Paessler, MD · ATOS Clinic, Heidelberg

  • Johan Bellemans, MD · UZ Leuven, Belgium

  • Holger Schmitt, MD · Heidelberg University

  • Gerhard Oberthaler, MD · Dr. Pierer Sanatorium, Salzburg, Austria

  • Uwe Pietzner, MD · Dietrich-Bonhöffer-Klinik, Altentreptow, Germany

  • Michael Jagodzsinki, MD · Hannover Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-05-31

Countries

  • Austria
  • Belgium
  • Germany

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 NCT00775892 on ClinicalTrials.gov