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CTRI Number  CTRI/2024/03/063659 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To explore safety and performance of Under Water Seal Drainage System (Romo Seal) in Adult & Paediatric subjects in Indian Population. 
Scientific Title of Study   A prospective, single arm, post market clinical follow-up of Under Water Seal Drainage System (Romo Seal) to explore its safety and performance in Adult & Paediatric subjects in Indian Population. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RG/CRO/CIP (UWSDS), Version 3.0, Dated 01 June 2023.  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Kala 
Designation  Principal & Dean 
Affiliation  GSVM Medical College 
Address  Ground Floor Principal Office GSVM Medical College Swaroop Nagar

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  8726555577  
Fax    
Email  dr_sanjay_kala@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Rohit Kumar 
Designation  Clinical Trial Assistant 
Affiliation  Romsons Group Private Limited 
Address  First Floor Regulatory Department 63-64 Industrial Estate Nunhai

Agra
UTTAR PRADESH
282006
India 
Phone  8006599926  
Fax    
Email  singhalrohit10000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anoop Batra 
Designation  Senior Manager- Regulatory Affairs 
Affiliation  Romsons Group Private Limited 
Address  First Floor Regulatory Department 63-64 Industrial Estate Nunhai

Agra
UTTAR PRADESH
282006
India 
Phone  9258105266  
Fax    
Email  anoopbatra2014@gmail.com  
 
Source of Monetary or Material Support  
Romsons Group Private Limited, 63-64, Industrial Estate, Nunhai, Agra-282006, Uttar Pradesh 
 
Primary Sponsor  
Name  Romsons Group Private Limited 
Address  63-64, Industrial Estate, Nunhai, Agra 
Type of Sponsor  Other [Medical Device Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Kala  G.S.V.M Medical College  Ground Floor Department of General Surgery Principal Office GSVM Medical College Swaroop Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 8726555577

dr_sanjay_kala@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Romo Seal Adult- GS-5020, Romo Seal Midi- GS-5031, Romo Seal Kid- GS-5032.  Device maximum use duration is not more than 7 days. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Males and Females Adult & Paediatric who are expected to undergo pleural and chest drainages for effective management of Chest Conditions.
2 Subject who can provide Informed Consent Form Adult in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics parent of child LAR Legally Acceptable Representative can provide Informed Assent Form Child.
3 The subject who is willing and able to comply with the requirement of the follow-up OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up.
 
 
ExclusionCriteria 
Details  1 Subject who present with medical emergency where treatment is more priority than the informed consent informed assent process.
2 Subject who cannot provide Informed Consent Form Adult such as unconscious mentally challenged subject OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc.
3 Any known allergy with any of the material of Under Water Seal Drainage System Romo Seal and its components.
4 Other conditions which in the opinion of investigators make the patient unsuitable for enrolment or could interfere with his her participation in and completion of the clinical investigation plan protocol.
5 Subject who is pregnant or breastfeeding.
6 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
7 Participation in another research study involving an active investigation within 30 days prior to consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Primary End Point of the study are as
1 Clinically intended for Under Water Seal Drainage procedure.
2 Facilitating unrestricted fluid drainage from the pleural cavity.
3 Facilitating the precise drained volume determination.
4 Improving the quality of life of the subject by achieving the intended purpose.
 		 Use duration of device is not more than 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
The Secondary End Point of the study are as
1 Materials Compatibility with the tissue & body fluids.
2 Dedicated Suction port efficacy facilitating regulated suctioning for efficient drainage.
3 Durability Sustainability of Device & fitment of the accessories with standard devices over required period of use.
 		 Use duration of device is not more than 7 days. 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   08/03/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 is a prospective, post marketing clinical follow-up of Under Water Seal Drainage System (Romo Seal) to evaluate its safety and performance in subjects who will undergo pleural and chest drainages for effective management of Chest Conditions using under water seal drainage procedures. Investigators and their team will be responsible for recruitment and ethical conduct of the follow-up. As per inclusion-exclusion criteria, subjects will be included in this follow-up. An informed consent / informed assent will be obtained from all subjects who are potential candidates prior to commencement of any follow-up related procedure.
All data will be collected in the follow-up specific Case Report Form.
 
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