CompletedNot Applicable

Efficacy and Safety of SurgiFill™ on Spinal Fusion

South Korea20 participantsStarted 2013-08

Plain-language summary

This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.

Who can participate

Age range

20 Years

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 who require spinal fusion
. Adult patients aged 20 or older

Exclusion criteria

. Patients or their family members with a history of an, or an ongoing, autoimmune disease
. Patients with a history of anaphylactic response
. Patients with hypersensitivity to grafting materials
. Patients with hypersensitivity to pig protein
. Patients with osteomyelitis in the surgery area
. Patients who are pregnant, breastfeeding, or planning to become pregnant
. Patients with other tumors or a non-curable disease
. Patients with a history of radiation therapy or cancer treatment within two years (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)

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

Volume change of bony fusion mass in the CT

Timeframe: 1week, 6month, and 12month

Trial details

NCT IDNCT02466048

SponsorCellontech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Spinal Fusion Acquired trials