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

NCT01706640 | Unknown DMC

• 1 other identifier: MM/CTVS/2012/001
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Cardio Vascular Outcome

  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

  18 months

Secondary Outcomes (2)

• Cardiovascular (sealing and adhesion prevention):

  18 months

• Thoracic and Lung (Sealing and Adhesion prevention)

  18 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing cardiovascular and thoracic surgery who require use of Coseal as a treatment strategy.
• Patient undergoing open, Video Assisted surgery and robotic surgery to be included and analysed as subgroups
• 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).

You may not qualify if:

• Known hypersensitivity to components of the investigational product
• Known Immune system disorders, immunodeficiency
• Concomitant use of any other anti-adhesion product
• Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
• Unplanned re-operation in case of use for anti-adhesion
• Contraindications for use of Coseal

Sponsors & Collaborators

• Medanta, The Medicity, India: lead

Study Sites (1)

Medanta, The Medicity

Gurgaon, Haryana, 122 001, India

Location

Study Officials

• Dr. Ali Z Khan, MS,FRCS,FRCS

  Medanta, The Medicity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Ali Z Khan, MS, FRCS,

CONTACT

9958001672; drkhanresearch@gmail.com

Dr. Shaiwal Khandelwal

CONTACT

9891878090; shaiwalk@gmail.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, Minimally Invasive & Robotic Thoracic Surgery

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 15, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

IN (1)