Creating a safe medical aid for infant rectal mucosal biopsy

JRCT ID: jRCTs062240072

Registered date:23/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Conditions that suggest Hirschsprung disease or Hirschsprung disease-related diseases
• Date of first enrollment: 23/10/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Was it possible to accurately make a pathological diagnosis using the biopsy specimen collected during rectal mucosal biopsy?
• Secondary Outcome: Complication rate (bleeding, gastrointestinal perforation, infection, full-thickness biopsy)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 5age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Saeki Isamu