NCT04511364Active, not recruiting
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe
Source: ClinicalTrials.gov · Last updated 31 Jan 2025
Brief summary (registry, in English)
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1). Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Aug 2020
- Start date
- 28 Aug 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- AgNovos Healthcare, LLC
- Diseases
- Osteoporosis
- NCT number
- NCT04511364
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 28 Aug 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subject was withdrawn from CONFIRM.
- Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
Who the study is looking for
- Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
- Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- Subject is capable of giving written informed consent to participate in the study.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Nikolaas Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.