PerQdisc Traditional Feasibility Trial.

Conditions

• Discogenic Low Back Pain

Eligibility Criteria

Sex

ALL

Age

22 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• PerQdisc — DEVICE
  PerQdisc Artificial Implant

Study Details

This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label. After a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.

Key Dates

Start date

Jan 10, 2025

Status verified

Aug 2025

Primary completion

Sep 30, 2026

Completion

Mar 31, 2030

Study Design

Enrollment

5 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: PerQdisc
  The PerQdisc device is the first in a new category of contained in-situ filled and then cured lumbar spinal implant. The PerQdisc is intended to replace the nucleus pulposus in a single lumbar disc level, preserve motion and alleviate pain. The PerQdisc is a silicone membrane (barrier membrane) configured to be filled with a room temperature vulcanizing silicone (RTVS) that will cure within minutes, resulting in a final shape that conforms to the nucleus space created by the surgical removal of the diseased or damaged nucleus pulposus.

Primary Outcome Measure

Clinical Composite Success [ Time Frame: 6 Months ]

Central Contacts

• Molly Bond
  1-800-484-1588
  [email protected]

Locations (8)

Find similar trials in Glendale, AZ

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