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CTRI Number  CTRI/2025/12/098906 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Robotic camera system to measure surgical wounds without touching the patient 
Scientific Title of Study   Development And Implementation of a Vision Based Tele-Surgical Robotic System for Remote Wound Assessment: A Descriptive Study in a Tertiary Care Hospital in Mandya 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1332-3151  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Lingaraju  
Designation  Associate professor and Neurosurgeon  
Affiliation  Mandya Institute of Medical Science  
Address  Unit C Department of General Surgery MIMS 3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India Mandya KARNATAKA 571401 India

Mandya
KARNATAKA
571401
India 
Phone  9480387075  
Fax    
Email  1983lingu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Lingaraju  
Designation  Associate professor and Neurosurgeon  
Affiliation  Mandya Institute of Medical Science  
Address  Unit C Department of General Surgery MIMS 3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India Mandya KARNATAKA 571401 India

Mandya
KARNATAKA
571401
India 
Phone  9480387075  
Fax    
Email  1983lingu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ing Vishwas Gowda P N  
Designation  Lead research and development engineer  
Affiliation  Manmed Dynamics LLP 
Address  206 Panakanahalli Kasaba hobli Konanahalli post Mandya Mandya KARNATAKA 571403 India

Mandya
KARNATAKA
571403
India 
Phone  8197239974  
Fax    
Email  vishwas.gowda@manmed.in   
 
Source of Monetary or Material Support  
Mandya Institute of Medical Sciences (MIMS) 3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India 
ManMed Dynamics LLP 206 Panakanahalli Kasaba hobli Konanahalli post Mandya Karnataka India 571403 
 
Primary Sponsor  
Name  Mandya Institute of Medical Science MIMS  
Address  3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India 
Type of Sponsor  Government 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 N Lingaraju  Mandya Institute of Medical Sciences (MIMS)  Department of Surgery 3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India Mandya KARNATAKA
Mandya
KARNATAKA 		 9480387075

1983lingu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee, MIMS, Mandya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T148||Other injury of unspecified body region,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Robotic depth camera based wound assessment   Non contact wound imaging using a teleoperated robotic arm carrying a close range three dimensional depth camera positioned above the wound. The system acquires close range colour and depth images to generate a three dimensional wound map and automatically calculate wound length, width, area and depth during a single assessment. 
Comparator Agent  Standard manual wound measurement by surgeon  Routine clinical wound measurement performed by the treating surgeon using a sterile measuring scale to record wound length, width and, where feasible, depth. These values are used as reference for comparison with the device based measurements. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged ten years and above with surface wounds or minor soft tissue trauma such as abrasions, lacerations, sutured wounds or postoperative surface wounds that can be safely exposed for imaging. Patients must be haemodynamically stable at the time of assessment. Written informed consent will be obtained from the patient or from a parent or legally authorised representative in case of minors, with assent from the child wherever appropriate. 
 
ExclusionCriteria 
Details  Life threatening trauma or deep internal injuries requiring immediate emergency surgery. Wounds with heavy active bleeding, extensive necrosis or gross infection where imaging could delay treatment. Large area burns or wounds where adequate exposure for imaging is not possible. Known pregnant women are excluded because pregnancy is considered a vulnerable condition and this initial feasibility study does not specifically evaluate risks or benefits in pregnant patients. Patients who are unable or unwilling to provide written informed consent are also excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Diagnostic accuracy of the automated machine learning based wound assessment system for estimating wound length, width and maximum depth compared with manual surgeon measurements, expressed as mean absolute difference in millimetres and percentage error for each parameter.  Day 0 at baseline wound imaging during the single study visit 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of wounds in which automated machine learning based measurements of wound length and width are within two millimetres of manual surgeon measurements.  Day 0 after completion of both automated and manual measurements for each patient 
Time required to complete wound assessment using the automated system from image capture to final measurements compared with time required for manual measurement by the surgeon.  Day 0 during each imaging session for all enrolled patients 
Performance of the automated segmentation and three dimensional reconstruction algorithm, assessed by investigator rating of wound boundary correctness and completeness on the reconstructed images.  Day 0 to end of study at the time of image analysis 
Usability and acceptability of the automated wound assessment system among surgeons and engineers measured using structured questionnaire scores.  Day 0 immediately after device use during the same visit 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/02/2026 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vishwas.gowda@manmed.in].

  6. For how long will this data be available start date provided 30-03-2026 and end date provided 30-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a single arm interventional medical device and diagnostic feasibility study to evaluate a robotic depth camera based system for non contact wound assessment in a tertiary care hospital in Mandya, India. A teleoperated robotic arm carrying a close range three dimensional depth camera is used to capture colour and depth images of surface wounds without touching the patient. Machine learning based algorithms automatically estimate wound length, width and maximum depth and generate a three dimensional wound map. In each patient these automated measurements are compared with standard manual measurements made by the treating surgeon using a sterile measuring scale. The study plans to enroll about fifty patients aged ten years and above who present with surface wounds or minor soft tissue trauma and are clinically stable. Primary outcomes include diagnostic accuracy of the automated measurements. Secondary outcomes include the proportion of wounds within a predefined error range, time taken for assessment, image and segmentation quality, and usability and acceptability of the system among surgeons. 
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