臨床研究等提出・公開システム

Exploratory clinical trail of HANZ to evaluate the efficacy and safety.

Clinical trail of HANZ to evaluate the efficacy and safety.

TANAKA Hiroyuki

Osaka University Hospital

2-15, Yamadaoka, Suita, Osaka

tanahiro-osk@umin.ac.jp

Development Division I

Nippon Zoki Pharmaceutical Co.,LTD

2-3, Hiranomachi, 4-chome, Chuo-ku, Osaka

+81-6-6203-0455

clindev-md@nippon-zoki.co.jp

Complete

Dec. 01, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(Carpal tunnel surgery)
1) Patients with a terminal latency (TL) of 6 ms or more before surgery.
2) Patients with a compound muscle action potential (CMAP) of 0.3 mV or more before surgery.

(Nerve suture)
1) Patients who do not have multiple nerve ruptures and require only one finger nerve suture.

(Carpal tunnel surgery)
1) Patients with a history of carpal tunnel surgery in the same hand.
2) Patients with diabetes or cervical spine lesions.
3) Patients receiving dialysis treatment.
4) Pregnant women, patients who may be pregnant, breast-feeding patients, and patients who wish to become pregnant during the clinical trial period.

(Nerve suture)
1) Patient who have fractures on target fingers that require nerve suture.
2) Patients who have damaged finger pulp where it is difficult to measure sensory function evaluation (SW test or two-point discrimination).
3) Patients who need surgery other than finger nerve suture at the same time.
4) Patients who need nerve regeneration inducer.
5) Patients with diabetes or cervical spine lesions.
6) Patients receiving dialysis treatment.
7) Pregnant women, patients who may be pregnant, breast-feeding patients and patients who wish to become pregnant during the clinical trial period.

Both

Carpal tunnel surgery due to carpal tunnel syndrome. Nerve suturing due to finger nerve rupture.

In carpal tunnel surgery, HANZ01 is partially covered or wrapped around the peripheral nerve that has opened the nerve strangulation site. In nerve suturing, HANZ01 is wrapped around the peripheral nerve where the torn finger nerve is sutured.

Efficacy
(Carpal tunnel surgery)
Change from baseline in terminal latency (TL).
(Nerve suture)
Change from baseline in SW test and two-point discrimination.

Safety
(Carpal tunnel surgery, Nerve suture)
Device Deficiencies, adverse events.

+81-6-6843-0101

Nov. 04, 2020

No

none