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Completed Phase 3 Interventional Results available

The Kiva® System as a Vertebral Augmentation Treatment

ClinicalTrials.gov ID: NCT01123512

Public ClinicalTrials.gov record NCT01123512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 9:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

Study identification

NCT ID
NCT01123512
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Benvenue Medical, Inc.
Industry
Enrollment
300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2010 (Type not available)
Primary completion
May 2013 (Actual)
Completion
May 2013 (Actual)
Last update posted
Oct 9, 2014

2010 – 2013

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
CORE Orthopaedic Medical Center Encinitas California 92021 —
El Camino Hospital Mountain View California 94040 —
Radiological Associates of Sacramento Sacramento California 95816 —
St. Mary's Spine Center San Francisco California 94117 —
Radiology Imaging Associates Englewood Colorado 80112 —
Mayo Clinic Jacksonville Jacksonville Florida 32224 —
Evanston Hospital Evanston Illinois 60201 —
Adventist Hospital Hinsdale Illinois 60521 —
Spine Institute of Louisiana Shreveport Louisiana 71101 —
Mayo Clinic-Rochester Rochester Minnesota 55905 —
Sierra Regional Spine Institute Reno Nevada 89509 —
Clinical Radiology of Oklahoma Edmond Oklahoma 73013 —
Penn State Hershey Medical Center Hershey Pennsylvania 17033 —
Medical University of South Carolina Charleston South Carolina 29425 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01123512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 9, 2014 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01123512 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →