TerminatedNot Applicable

Spine Registration Using 3D Scanning

Stopped: Low enrollment of subjects

United States2 participantsStarted 2021-08-31

Plain-language summary

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.

Who can participate

Sex

ALL

See this in plain English?

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

Inclusion criteria

. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
. Clinically planned for spine surgery.
. Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study.

Exclusion criteria

. Language problems that would prevent from properly understanding instructions.
. Requirement of an interpreter.
. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
. Special populations: pregnant women, prisoners.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Spine Registration

Timeframe: Throughout the surgical procedure

Trial details

NCT IDNCT05195580

SponsorAdvanced Scanners Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11-02

View on ClinicalTrials.gov More Spinal Fusion trials

Who can participate

Sex

ALL

See this in plain English?

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

Inclusion criteria

. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
. Clinically planned for spine surgery.
. Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study.

Exclusion criteria

. Language problems that would prevent from properly understanding instructions.
. Requirement of an interpreter.
. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
. Special populations: pregnant women, prisoners.