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NCT03113786 · ClinicalTrials.gov registry record · Phase 4
CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients
A Phase 4 study, sponsored by Amniox Medical.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT03113786: Completed Phase 4 study, sponsored by Amniox Medical.
NCT03113786 is a Phase 4 study that has completed, run by Amniox Medical. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03113786, a Phase 4 study, has completed, sponsored by Amniox Medical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back \& leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.
Primary Outcome
To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the Oswestry Disability Index scales for both back \& leg pain
Interventions
- OTHER CLARIX™100
- OTHER CLARIX CORD 1K
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-11-02 |
| Est. Completion | 2020-04-21 |
| Phase | Phase 4 |
What the finished NCT03113786 record still lists
NCT03113786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which CLARIX™100 is the first listed.
NCT03113786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03113786 about?
NCT03113786 is a clinical study titled "CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients". The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back \& leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized stud...
What is the current status of trial NCT03113786?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2011-11-02. Estimated completion is 2020-04-21.
What interventions are being tested in trial NCT03113786?
The interventions under investigation include: CLARIX™100 (OTHER), CLARIX CORD 1K (OTHER).
Who is sponsoring clinical trial NCT03113786?
This trial is sponsored by Amniox Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03113786's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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