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

August 31, 2026 updated by: Murdoch Childrens Research Institute

Validation of Body Surface Colonic Mapping, a Non-invasive Tool for Assessing Colonic Motility in Children

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Potential participants will be identified by RCH surgeon, Prof. Sebastian King (Paediatric Colorectal Surgeon). Patients will be identified following outpatient review or referral to RCH (Department of Paediatric Surgery), when colonic motility assessment is recommended for investigation of bowel dysfunction. All patients will be reviewed in clinic by an independent paediatric gastroenterologist (Dr Mark Safe), who has undergone post-fellowship training in the assessment of paediatric gastrointestinal motility.

All patients planned to undergo colonic motility assessment will be screened for study eligibility. Screening for eligibility will be undertaken by study investigators the electronic medical record (EPIC).

Once identified, patients will be reviewed in the monthly motility clinic with Prof. King and Dr Safe, which is part of the standard of care at RCH prior to colonic manometry. At that time, after completion of the clinical review, families and patients will be given verbal information about the opportunity to take part to the research study while undergoing colonic manometry. Further information about the study (Recruitment letter and Participant information) will be emailed to them after the consultation. This will follow-up with a phone call to the family by Dr Comella after a week to establish if the family and patient are interested in taking part to the research study. If consenting, this will be documented and the relevant hospital admissions organised. Written consent will be obtained on the day of the first in-person appointment. It will be explicit in the initial and all subsequent contact that there is no imperative for the child to participate; patient care will not be compromised by electing not to participate in the project.

Participants will be able to stop the study at any time they would like if they do not want to complete it. They will be undertaking colonic manometry as part of their clinical indication by their physician, who will run the test to gain information for their clinical management. The BSCM data will be part of the research project, which aims to compare these data to the current colonic motility assessment gold-standard that is colonic manometry. The family or patient can stop the research side of the study at any stage.

Participants will not receive incentives or compensation for participation.

As previously specified, eligible participants who consent will undergo colonoscopy and placement of the colonic motility catheter for colonic manometry, according to usual RCH practice as per their clinical indication for the test. This is the current gold-standard of care for colonic motility assessment. The study recruits patients that are already undertaking colonic manometry as part of their clinical care. These data will therefore be clinical data that will be recorded independently from the research project. The research project aims to ask the families to be willing for those recordings to be used for research purposes as well and be compared to BSCM recordings that would be taken at the same time as colonic manometry if the family/patient are willing to consent to the research study. If participating in the research study, the family/patient will be asked to also attend a hospital appointment to have BSCM recording only a couple of weeks ahead of the HRCM/BSCM recording, in order to have BSCM data from the same patient with the unprepared and prepared colon.

BSCM includes a sticky grid pad device connected to a reader that detects bowel motility. The application of body surface mapping in paediatric populations is supported by established research with a study successfully utilized gastric body surface mapping in a cohort of 107 patients aged 12-17. Furthermore, subsequent data from Dr. Humphrey's doctoral research (currently pending peer-review) demonstrates that the electrode array is effective in children as young as 5 years of age.

Adaptability for Paediatric Use:

To accommodate the smaller physical stature of younger patients, the surface electrode array is designed to be customized (cut to fit) the child's abdominal dimensions without compromising signal integrity.

As previously stated, BSCM includes a sticky grid pad device connected to a reader that detects bowel motility. Under the initial guidance of a consultant from Alimetry, Dr. Comella will oversee the application of the BSCM electrode array to the patient's abdomen. This is a standardised, non-invasive procedure that has been safely performed on hundreds of adult patients.

  1. Simultaneous HRCM and BSCM Recording:

    For patients undergoing concurrent colonic manometry, an abdominal X-ray is already standard clinical practice to verify the precise anatomical location of the catheter sensors. During these sessions:

    • The BSCM array will be positioned on the abdomen directly over the catheter.
    • Specific care will be taken to ensure the array is aligned to capture signals from the descending and sigmoid colon.
  2. Standalone (Unprepared Colon) Recording

When recording from the unprepared colon (where no manometry catheter is present), no X-ray will be taken, minimizing unnecessary radiation exposure. Instead, placement will rely on established anatomical landmarks:

  • Positioning: The array will be cantered 2-4 cm to the left of the midline on the lower abdomen.
  • Orientation: The lower boundary of the array will typically align with the patient's waistline.

The device will be on the patients' abdomen until for the whole duration of the investigation.

To be useful as a diagnostic tool, BSCM must detect and differentiate two major types of motility:

  1. high amplitude propagating contractions (HAPC);
  2. cyclic motor patterns.

Clinical Benchmarks for Response:

We will apply our established manometric criteria to the BSCM data to determine clinical significance:

  • Meal Response: a > 20% increase in MI.
  • Pharmacological Response: a > 60% increase in MI following bisacodyl administration.

Validation Strategy:

Beyond the numerical MI, our analysis will compare the timing and duration of the contractile increases across both modalities. This methodology mirrors a recent study involving combined colonic manometry and BSCM in adults with chronic constipation; a study currently under its second revision with the American Journal of Gastroenterology.

Preliminary studies by Professor Greg O'Grady in healthy adults showed BSCM could detect an electrical increase in activity after a meal and this was later correlated with colonic manometry . There is also evidence that BSCM can detect a laxative stimulant-induced HAPC using bisacodyl. This is a hugely important step because it means that, in adults, it is possible to identify distinct spectral signatures that represent the two commonly recorded manometry signals. All these data are from studies carried in an adult population. There is now need to show the same recording may be made in children and then develop the automated algorithms to reliably extract these signals, similar to what has already been achieved with body surface gastric mapping in people aged 12yo and older.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • The Royal Children's Hospital / Murdoch Children's Research Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Assia Comella, MBBS(Hons), BMedSc(Hons), GDCH
        • Principal Investigator:
          • Sebastian King, MBBS, PhD, FRACS
        • Sub-Investigator:
          • Mark Safe, MBBS (Hons), FRACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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).

  2. 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.

  3. Is unable to attend for and/or engage in consent process or assessments, including due to language restriction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paediatric patients with bowel dysmotility
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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])
Time Frame: 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.
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])
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Standalone visit for BSCM recording (duration about 2 hours). Main visit for the BSCM and HRCM via colonoscopy (duration about 6 hours).
The effects of bowel preparation upon colonic motor patterns (MI) will be studied by comparing the BSCM in children having undergone bowel preparation prior to the BSCM and HRCM ["prepared colon"] with the MI in children who have not received bowel preparation at the standalone BSCM [unprepared "physiological state" colon]. Bowel preparation includes laxatives, a clear fluid diet for 24 hours, an anaesthetic and gas inflation at colonoscopy.
Standalone visit for BSCM recording (duration about 2 hours). Main visit for the BSCM and HRCM via colonoscopy (duration about 6 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Murdoch Childrens Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal Children's Hospital
Flinders University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sebastian K King, MBBS, PhD, FRACS, Royal Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 126887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared with anyone outside the primary research group, who will conduct the project including data collection and analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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