RecruitingNot Applicable

RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

Germany, Spain100 participantsStarted 2021-05-19

Plain-language summary

This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is a male or female 50 years of age or older at time of study treatment.
✓. Criterion omitted
✓. Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
✓. This VCF meets all of the following criteria:
✓. Fracture due to diagnosed or presumed underlying osteoporosis
✓. VCF from T1 to L5 inclusive
✓. Fracture age ≤6 months at time of treatment
✓. Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 50% based on X-ray at baseline.

Exclusion criteria

✕. Target VCF is due to underlying or suspected tumor.
✕. Target VCF is due to high-energy trauma.
✕. Target VCF is diagnosed as an osteonecrotic fracture.
✕. Target VCF has segmental kyphosis of \> 30°.
✕. Target VCF is unstable including split or burst fractures.
✕. Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF).

What they're measuring

Change in Back Pain from Baseline

Timeframe: 12 months

Trial details

NCT IDNCT04821739

SponsorAgNovos Healthcare, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Adam Lowe

240-753-6416 alowe@agnovos.com

View on ClinicalTrials.gov More Vertebral Compression Fracture trials