Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 8:36 PM
Study NCT ID:
NCT06971835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INDUCE: A Prospective 2-Year Spine Registry
Sponsor:
Red Rock Regeneration Inc.
Organization:
Study Overview
Official Title:
Assessment of Safety and Clinical Effectiveness of Induce NMP® in Degenerative Spine Surgery: A Prospective 2-Year Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine.
The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.
The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.
Detailed Description:
This is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 US sites. All subjects who meet study entrance criteria and planned to be treated with NMP Fibers and/or Micro Particulates as part of their cervical or lumbar spinal surgery will be invited to participate in the study.
PRIMARY ENDPOINTS
* Safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s)
* Effectiveness - presence of fusion as measured by x-rays and if available CT.
SECONDARY ENDPOINTS
Beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables:
* Baseline demographics and medical history
* Duration of hospitalization
* Operative time
* Estimated blood loss
* Neurological status
* Subject patient reported outcomes as applicable including, but not limited to:
* Oswestry Disability Index (ODI)/ Neck Disability Index (NDI)
* Visual Analog Scale (VAS) Pain
* Veteran Rand 12-Item Health Survey (VR-12)
PRIMARY ENDPOINTS
* Safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s)
* Effectiveness - presence of fusion as measured by x-rays and if available CT.
SECONDARY ENDPOINTS
Beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables:
* Baseline demographics and medical history
* Duration of hospitalization
* Operative time
* Estimated blood loss
* Neurological status
* Subject patient reported outcomes as applicable including, but not limited to:
* Oswestry Disability Index (ODI)/ Neck Disability Index (NDI)
* Visual Analog Scale (VAS) Pain
* Veteran Rand 12-Item Health Survey (VR-12)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: