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An Open Label,Observational, Real Time Data Capturing of Usage & Outcome of Coseal

This study is not yet open for participant recruitment.
Verified October 2012 by Medanta, The Medicity, India
Sponsor:
Information provided by (Responsible Party):
Dr. Ali Zamir Khan, Medanta, The Medicity, India
ClinicalTrials.gov Identifier:
NCT01706640
First received: October 8, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage, Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re- Operative procedures.

Objective of this study is to assess current practice pattern and best practice sharing of usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post surgical adhesion enforcement of suture lines in lung resection procedures (3) From this data to document and generate a real life experience on the use of Coseal in cardio vascular and thoracic surgery.

Number of expected patient enrollment is 750 from 20 participating sites.


Condition
Surgery

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open- Label,Multicentre, Observational, Prospective, Real-time Data Capturing of Usage, Outcome & Physician Satisfaction of Coseal in Cardio- Vascular- Thoracic Operative and Re- Operative Procedures

Resource links provided by NLM:

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Further study details as provided by Medanta, The Medicity, India:

Primary Outcome Measures:
  • Cardio Vascular Outcome [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    To report the effectiveness and safety of COSEAL in the control of anastomotic suture line and needle hole suture bleeding during vascular reconstruction by checking the incidence of immediate anastomotic sealing and the presence of persistent intra-operative and postoperative bleeding


Secondary Outcome Measures:
  • Cardiovascular (sealing and adhesion prevention): [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    To Capture total operative time,nature and duration of first operation,nature and duration of redo operation, and time for dissection from sternotomy to end of dissection for prevention of adhesions )

  • Thoracic and Lung (Sealing and Adhesion prevention) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient falling under inclusion criteria can take part in to bthe study

Criteria

Inclusion Criteria:

  1. Patients undergoing cardiovascular and thoracic surgery who require use of Coseal as a treatment strategy.
  2. Patient undergoing open, Video Assisted surgery and robotic surgery to be included and analysed as subgroups
  3. Written informed consent obtained from the patient or legal representative for data collection post surgery in patients who had Coseal used intraoperatively (data privacy laws).

Exclusion Criteria:

  1. Known hypersensitivity to components of the investigational product
  2. Known Immune system disorders, immunodeficiency
  3. Concomitant use of any other anti-adhesion product
  4. Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
  5. Unplanned re-operation in case of use for anti-adhesion
  6. Contraindications for use of Coseal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706640

Contacts
Contact: Dr. Ali Z Khan, MS, FRCS, 9958001672 drkhanresearch@gmail.com
Contact: Dr. Shaiwal Khandelwal 9891878090 shaiwalk@gmail.com

Locations
India
Medanta, The Medicity Not yet recruiting
Gurgaon, Haryana, India, 122 001
Principal Investigator: Dr. Ali Z Khan, MS,FRCS,            
Sponsors and Collaborators
Medanta, The Medicity, India
Investigators
Principal Investigator: Dr. Ali Z Khan, MS,FRCS,FRCS Medanta, The Medicity
  More Information

No publications provided

Responsible Party: Dr. Ali Zamir Khan, Head of Department, Minimally Invasive & Robotic Thoracic Surgery, Medanta, The Medicity, India
ClinicalTrials.gov Identifier: NCT01706640     History of Changes
Other Study ID Numbers: MM/CTVS/2012/001
Study First Received: October 8, 2012
Last Updated: October 12, 2012
Health Authority: India: Ministry of Health

ClinicalTrials.gov processed this record on May 19, 2013