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Creating a safe medical aid for infant rectal mucosal biopsy

Efficacy and safety of 3D-printed medical devices for rectal mucosal biopsy (K-PUNCH method) in infants - Efficacy and safety of new medical devices for rectal mucosal biopsy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062240072
Enrollment
10
Registered
2024-10-23
Start date
2025-02-11
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

Conditions that suggest Hirschsprung disease or Hirschsprung disease-related diseases Hirshsprung

Interventions

In this study, we will actually perform rectal mucosal biopsies on patients using an auxiliary instrument for rectal mucosal biopsies made from resin using a 3D printer based on 3D printer blueprints.

Sponsors

Saeki Isamu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children suspected of having Hirschsprung disease or Hirschsprung disease-related diseases Infants aged 0-5 years Patients whose legal guardian has given written consent to participate in this study

Exclusion criteria

Exclusion criteria: Ages 6 and over Children with bleeding tendency History of anal surgery Second and subsequent biopsies Parents who have a conflict of interest, such as a principal investigator directly involved in this research or other clinical research, an employee of the conducting medical institution, or a family member of such an employee or principal investigator, etc.

Design outcomes

Primary

MeasureTime frame
Was it possible to accurately make a pathological diagnosis using the biopsy specimen collected during rectal mucosal biopsy?

Secondary

MeasureTime frame
Complication rate (bleeding, gastrointestinal perforation, infection, full-thickness biopsy)

Contacts

Public ContactIsamu Saeki

Hiroshima University Hoepital

isaeki@hiroshima-u.ac.jp+81-82-257-5216

Outcome results

None listed

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