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CTRI Number  CTRI/2026/02/104641 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A WEARABLE GUT ACTIVITY MONITOR 
Scientific Title of Study   WEARABLE GUT ACTIVITY MONITOR – A NON-INVASIVE WEARABLE PATCH OR BELT THAT TRACKS GUT SOUNDS AND MOTILITY THROUGH ACOUSTIC SENSORS 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAUTHAM PALLAMPARTHY  
Designation  Post graduate,General Medicine  
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Chennai TAMIL NADU 602105 India

Chennai
TAMIL NADU
602105
India 
Phone  9566250825  
Fax    
Email  p.gautham.2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ananthakumar PK 
Designation  Professor,Dept of General Medicine  
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Chennai TAMIL NADU 602105 India

Chennai
TAMIL NADU
602105
India 
Phone  9620916481  
Fax    
Email  ananthakumarpk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ananthakumar PK 
Designation  Professor,Dept of General Medicine  
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Chennai TAMIL NADU 602105 India

Chennai
TAMIL NADU
602105
India 
Phone  9620916481  
Fax    
Email  ananthakumarpk@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu 
 
Primary Sponsor  
Name  Saveetha Medical College and Hospital 
Address  Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gautham Pallamparthy   SAVEETHA MEDICAL COLLEGE AND HOSPITAL  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Chennai TAMIL NADU
Chennai
TAMIL NADU 		 9566250825

p.gautham.2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil intervention as it is an observational study   Nil intervention as it is an observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age greater than or equal to 18 years
2. Hospitalized patients in medical or surgical wards
3. Hemodynamically stable patients
4. Ability to provide informed consent
5. No concurrent investigational monitoring devices 
 
ExclusionCriteria 
Details  1. Recent abdominal surgery ( less than 72 hours ago)
2. Presence of abdominal stoma
3. Pregnancy
4. Extensive abdominal wounds or dressings
5. Altered sensorium or uncooperative patients
6. Patients requiring intensive care or mechanical ventilation
7. Acute bowel obstruction requiring emergency intervention 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Interobserver agreement among clinicians assessing bowel sounds, measured using Fleiss’ kappa statistic  Day 1, day 30,day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Agreement between clinician consensus and wearable gut activity monitor output, measured using Cohen’s kappa
2. Comparison of variability between clinician-based bowel sound assessment and device-based assessment 		 Day 1, day 30,day 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This prospective observational study evaluates the reliability of traditional bowel sound auscultation compared with a wearable acoustic monitoring device. Three clinicians independently classify bowel sounds in hospitalized adults, and their agreement is compared with objective device-generated data. The study aims to quantify interobserver variability, assess clinician–device agreement, and highlight the limitations of subjective bedside examination. Findings are expected to demonstrate poor to moderate clinician agreement and greater consistency with device-based monitoring, supporting the role of objective technologies in abdominal assessment.

 
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