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Safety and performance confirmation study with dMD-003

Safety and performance confirmation study with dMD-003 - Study to evaluate the safety and performance of dMD-003 in patients scheduled to undergo planned two-stage hepatectomy -

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2032240323
Enrollment
15
Registered
2024-09-10
Start date
2024-11-19
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Metastatic liver cancer

Interventions

The study device (dMD-003) is applied, in principle, just under the wound (around the cut surface of the liver) immediately before wound closure in the initial surgery of a planned two-stage hepatecto

Sponsors

Aihara Fumiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with bilobar multiple liver metastasis from colon or rectal cancer who are eligible for a hepatectomy only if a planned two-stage hepatectomy is used. (2) Patients scheduled to undergo a second-stage hepatectomy at 2 to 12 weeks after the date of the initial hepatectomy. Other criteria.

Exclusion criteria

Exclusion criteria: (1) Patients scheduled to undergo open resection along with the initial hepatectomy in the case of a concurrent primary colon or rectal tumor. (2) Patients with a history of open surgery for a primary colon or rectal tumor. (3) Patients who have previously undergone open surgery of the liver, bile duct, or upper abdomen. Other criteria.

Design outcomes

Primary

MeasureTime frame
(1) Zuhlke classification (2) TORAD score

Contacts

Public ContactPublic relations

Mochida Pharmaceutical Co., Ltd.

webmaster@mochida.co.jp+81-332256303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026