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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Dr. Ali Zamir Khan, Medanta, The Medicity, India.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706640
First Posted: October 15, 2012
Last Update Posted: October 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ali Zamir Khan, Medanta, The Medicity, India
  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

Further study details as provided by Dr. Ali Zamir Khan, Medanta, The Medicity, India:

Primary Outcome Measures:
  • Cardio Vascular Outcome [ Time Frame: 18 months ]
    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 ]
    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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 8, 2012
First Posted: October 15, 2012
Last Update Posted: October 15, 2012
Last Verified: October 2012