Comparison of a New Non-invasive Device With the Current Invasive Gold-standard Investigation to Assess Movement and Function of the Large Bowel in Children

NCT07789782 | Not Yet Recruiting

• 1 other identifier: 126887
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the new non-invasive device (Body Surface Colonic Mapping) works to accurately assess colonic movement and function in children.The main questions it aims to answer are:

• Are Body Surface Colonic Mapping (BSCM) recordings comparable with gold-standard colonic manometry recordings (HRCM - High Resolution Colonic Manometry) in the paediatric population?
• What are the effects of bowel preparation on colonic function assessed using BSCM? Children with clinical recommendation of colonic and/or anorectal manometry (clinical tests used to assess colonic function) for investigation of persistent bowel dysfunction symptoms will be invited to participate. We will perform and compare simultaneous recordings of manometry and BSCM in children, in order to demonstrate same colonic function measurements recorded by the two devices in this population. Eligible participants who consent to inclusion in the study will undergo colonoscopy and placement of a large bowel catheter, according to usual Royal Children's Hospital (RCH) practice. These involve administration of oral laxatives for bowel preparation and maintaining a clear fluids diet 24 hours prior to the investigation. Ahead of the simultaneous devices recordings, patients will also be invited to attend the hospital 2-4 weeks prior to have non-invasive BSCM recording only. The aim of this part of the study is to have a BSCM recording in the same patient once with the "physiological state" colon (early hospital visit without any bowel preparation administration) and once with the "non-physiological state" colon (time of colonoscopy, colonic manometry and BSCM with bowel preparation).

Conditions

Bowel Dysfunction; Dysmotility; Hirschsprung Disease; Anorectal Malformations; Constipation; Functional Constipation (FC)

Keywords

bowel dysmotility; constipation; paediatric; pediatric; Hirschsprung disease; Anorectal malformations

Outcome Measures

Primary Outcomes (2)

• Outcome measure 1: Motility Index (MI) as measured by Body Surface Colonic Mapping (BSCM) (to be compared with the Motility Index of the alternative method [colonic manometry])

  BSCM measures the electrical activity underlying colonic contractions. Data captured via BSCM can be characterised as a MI. This will be compared with that for the alternative method recordings (colonic manometry).

  On the day of the main investigation, from the beginning of colonic manometry and BSCM assessments until the end of the tests, with an estimated testing time of 6 hours.

• Outcome measure 2: Motility Index (MI) as measured by colonic manometry (to be compared with the Motility Index of the alternative method [Body Surface Colonic Mapping])

  Colonic manometry measures the contact force of contractile activity within the gut, recorded as a series of pressure waves. These fluctuations in the pressure profile are quantified using a MI.

  On the day of the main investigation, from the beginning of colonic manometry and BSCM assessments until the end of the tests, with an estimated testing time of 6 hours.

Secondary Outcomes (1)

• Change in Motility Index as measured by BSCM on the day of the main investigation (BSCM and HRCM via colonoscopy) versus a stand-alone BSCM-only assessment performed 2-4 weeks beforehand.

  Standalone visit for BSCM recording (duration about 2 hours). Main visit for the BSCM and HRCM via colonoscopy (duration about 6 hours).

Study Arms (1)

Paediatric patients with bowel dysmotility

EXPERIMENTAL

Paediatric patients with bowel dysmotility and indications for colonic manometry investigation will have Body Surface Colonic Mapping applied to their abdomen for comparison with colonic manometry recordings.

Device: Body Surface Colonic Mapping

Interventions

Body Surface Colonic Mapping DEVICE

BSCM includes a sticky grid pad device connected to a reader that detects bowel motility. The sticky gid pad is the single-use disposable part of BSCM, so after use in each participant, the pads are disposed of. The grid pads are made of 64 electrodes and can be cut along pre-designed marks to allow for appropriate fitting on the child's abdomen. The sticky grid will be appropriately sized and applied to the patients' abdomen in the operating theatre recovery room after colonoscopy and correct positioning in relation to the manometry catheter will be ensured with an abdominal X-Ray (AXR). The device will be on the patients' abdomen until for the whole duration of the investigation (about 6 hours).

Paediatric patients with bowel dysmotility

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Is aged 18 years or less at enrolment.
• Has undergone a repeat rectal biopsy to exclude a retained segment of aganglionic colon (Hischsprung disease (HD) cohort only).

You may not qualify if:

• Has undergone primary surgical repair of HD or (anorectal malformation (ARM) within 12 months of the study. Is less than twelve months following primary surgical correction of HD or ARM (HD or ARM cohorts only).
• Has a prior diagnosis of:
• i. Intellectual disability or a spinal abnormality, such that continence is unlikely to be attainable; ii. Malignant (cancer) conditions, receiving chemotherapy; iii. GMFCS IV or V.
• Is unable to attend for and/or engage in consent process or assessments, including due to language restriction.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Royal Children's Hospital: collaborator
• Flinders University: collaborator

Study Sites (1)

The Royal Children's Hospital / Murdoch Children's Research Institute

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Intestinal Diseases; Hirschsprung Disease; Anorectal Malformations; Constipation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Megacolon; Colonic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastian K King, MBBS, PhD, FRACS

  Royal Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian K King, MBBS, PhD, FRACS

CONTACT

+61433994110; sebastian.king@rch.org.au

Misel Trajanovska, B.Sc(Hons), PhD

CONTACT

+61 418389216; misel.trajanovska@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)