Study of the safety of Organ pocket during operation of kidney transplant recipients

Single arm and open-label single-center study of the safety and usefulness of Thermal Barrier Bag (Organ pocket) during operation of kidney transplant recipients (First in human trial)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs062210034

Enrollment

Registered

2021-09-09

Start date

2021-10-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Kidney Transplantation End stage renal disease

Interventions

The Kidney graft is put into the Thermal Barrier Bag (TBB) at ex vivo cooling perfusion and kept it during vascular anastomosis. After vascular anastomosis is complete, TBB is carefully removed from k

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pre-kidney transplant patients aged 20 to 70 years old at the time of obtaining written consent. 2) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to resin. 2) Any other patients regarded unsuitable by the principal investigator or sub-investigators

Design outcomes

Primary

Measure	Time frame
1) Adverse event 2) Device failure 3) Laboratory value 4) Vital sign 5) Respiratory and circulatory dynamics during vascular anastomosis of recipient operation	—

Secondary

Measure	Time frame
1) Organ surface temperature during anastomosis in kidney transplant recipient surgery 2) Anastomosis time in kidney transplant recipient surgery	—

Contacts

Public ContactKentaro ide

Hiroshima University Hospital

ideken@hiroshima-u.ac.jp+81-82-257-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026