Prospective clinical trial to evaluate the efficacy and safety of MegaNerve Prime® allogeneic nerve graft implantation in thigh flap elevation

A comparative, single-center, randomized, prospective clinical study to evaluate the efficacy and safety of applying the allogeneic nerve graft MegaNerve Prime® to nerve defects resulting from damage during anterolateral thigh flap harvesting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010092

Enrollment

Registered

2024-12-27

Start date

2024-12-31

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This study is a comparison, single institution, randomization, and prospective clinical study (Pilot study) to evaluate the effectiveness and stability of MegaNerve Prime®, which is c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria in order to participate in this clinical trial. Participation in clinical studies can only be made if all of the following criteria are met. 1) Patients aged 19 to under 80 2) a patient with a tissue defect whose anterior lateral femoral vitreous valve is scheduled 3) Patients who agree to the clinical study and are able to follow up within the trial period 4) Patients whose peripheral nerves are damaged by disease and trauma, accompanied by peripheral nerve damage or a loss of nerves

Exclusion criteria

Exclusion criteria: Anyone who falls under any of the following conditions cannot participate in this clinical trial. 1) a patient undergoing chemotherapy 2) Patients with underlying diseases such as infectious diseases, autoimmune diseases (especially rheumatoid diseases), and blood coagulation disorders 3) a patient with uncontrolled diabetes 4) a pregnant woman or nursing woman 5) Other patients judged by the research director to be difficult to participate in the study

Design outcomes

Primary

Measure	Time frame
sensitivity evaluation	—

Secondary

Measure	Time frame
Satisfaction Evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Chul Suh

Yonsei University Health System, Severance Hospital

ycsuh@yuhs.ac+82-2-2228-2225

Outcome results