Confirmatory trial with dMD-003

Confirmatory trial with dMD-003 - Non-inferiority confirmatory study of dMD-003 to Seprafilm in patients with primary rectal cancer scheduled to undergo temporary loop ileostomy -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2072230089

Enrollment

150

Registered

2023-11-11

Start date

2024-01-12

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

Rectal cancer

Interventions

The study device (dMD-003 or Seprafilm) is applied, in principle, under the midline incision immediately before wound closure in a temporary ileostomy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with initial and primary rectal cancer. (2) Patients with cStage 0 to cStage III cancer. (3) Patients who are scheduled to undergo laparoscopic or robot-assisted rectal resection in which a temporary ileostomy is scheduled to be performed. Other criteria.

Exclusion criteria

Exclusion criteria: (1) Patients who have previously undergone surgery in the abdominal cavity (excluding appendicitis surgery). (2) Patients with cStage IV cancer. (3) Patients who are scheduled to have samples removed from a site other than the midline incision. Other criteria.

Design outcomes

Primary

Measure	Time frame
Presence or absence of adhesion.	—

Contacts

Public Contactrelations Public 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