Post-market clinical follow-up study for flowable gelatin haemostatic matrix kit in real-world patients to stop bleeding during surgery
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/06/068248
- Lead Sponsor
- Aegis Lifesciences Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. A Patient requiring haemostasis in surgical procedures where
control of bleeding by standard surgical techniques is ineffective
or impractical.
2. A Patient or their legally designated guardian is willing to sign
Informed Consent Form (ICF)
3. A Patient willing to comply with the requirements given in ICF
including the requirements for participating till last follow-up.
4. All patients who are not allergic to gelatin.
1. A Patient currently participating in another clinical study.
2. A Patient having known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombasthenia,
haemophilia, or Von Willebrand disease)
3. A Patient having allergy to porcine gelatin
4. A Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating.
5. A Patient undergoing ophthalmic surgery.
6. A Patient requiring closure of skin incisions by Flogel because it
may interfere with the healing of skin edges.
7. A Patient requiring haemostasis in intravascular compartments because of the risk of embolization.
8. A Patient requiring hemostasis in the absence of active blood flow e.g. while the vessel is clamped or bypassed as it may result
in risk of intravascular clotting from intravascular injection.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method