Innovative Spinopelvic Solutions with Real-World Evidence

Study Purpose

INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age > 21 at time of screening. 2. Patient will undergo a procedure utilizing an iFuse Implant family product. 3. Patient is comfortable communicating in written and spoken English. 4. Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer. 5. Patient is willing and able to provide informed consent to participate.

Exclusion Criteria:

1. Patient has fibromyalgia. 2. Patient has a pain pump. 3. Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06706908
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

SI-BONE, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robyn Capobianco, PhD
Principal Investigator Affiliation SI-BONE
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

SI-BONE, Santa Clara, California

Status

Address

SI-BONE

Santa Clara, California, 94087