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NCT02161016 · ClinicalTrials.gov registry record · Phase 4

A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft

A Phase 4 study, sponsored by RTI Surgical.

Terminated
Registry status
Phase 4
Development phase
1
Enrollment target

NCT02161016 is a Phase 4 study that was terminated before completion, run by RTI Surgical. The registered enrollment target is 1 participants.

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The verdict

NCT02161016, a Phase 4 study, was terminated before completion, sponsored by RTI Surgical.

TERMINATED
Registry status
Phase 4
Development phase
1 participants
Enrollment target

Study Summary

This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.

Interventions

  • DEVICE map3

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2014-06
Est. Completion 2015-01
Phase Phase 4

Sponsor

RTI Surgical

12 total trials

What the Registry Record Tells You About NCT02161016

The ClinicalTrials.gov registry entry for NCT02161016 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI Surgical, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which map3 is the first listed.

NCT02161016 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02161016 about?

NCT02161016 is a clinical study titled "A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft". This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the ...

What is the current status of trial NCT02161016?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2014-06. Estimated completion is 2015-01.

What interventions are being tested in trial NCT02161016?

The interventions under investigation include: map3 (DEVICE).

Who is sponsoring clinical trial NCT02161016?

This trial is sponsored by RTI Surgical, which has 12 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.