Long-term safety evaluation of NVDX3 treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term safety of patients who have previously been treated with NVDX3, focusing on those who participated in earlier core clinical trials. Participants will undergo yearly follow-up safety visits for a duration of 10 years to monitor any potential adverse effects or complications associated with the treatment. The study aims to gather comprehensive safety data to ensure the well-being of patients over an extended period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient being implanted with NVDX3.
2. Previously participated to one of the NVDX3 core clinical trials.
3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.

Exclusion Criteria:

No exclusion criteria are applicable.

Where it's running

• Centre Hospitalier de Luxembourg
  Luxembourg, Luxembourg Recruiting

Study contacts

• Principal investigator: Torsten Gerich, MD — Centre Hospitalier du Luxembourg
• Study coordinator: Denis Dufrane, MD
• Email: clinical@novadip.com
• Phone: +3210779220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.