Clinical trail of HANZ to evaluate the efficacy and safety.

JRCT ID: jRCT2052200091

Registered date:04/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Carpal tunnel surgery due to carpal tunnel syndrome. Nerve suturing due to finger nerve rupture.
• Date of first enrollment: 18/01/2021
• Target sample size: 33
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: TANAKA Hiroyuki