To evaluate safety and efficacy of MERIZELLE ORC U.S.P for achievement of hemostasis across several surgical procedures.

MERIZELLEâ?¢ ORC U.S.P: A prospective, multi-centre, single-arm, observational, post marketing surveillance study to evaluate safety and efficacy of MERIZELLE ORC U.S.P for achievement of hemostasis across several surgical procedures. - MERIZELLEâ?¢ ORC U.S.P

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/01/007710

Enrollment

185

Registered

2017-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: MERIZELLEâ?¢ ORC U.S.P: MERIZELLEâ?¢ ORC U.S.P for achievement of hemostasis across several surgical procedure, Different size of product is used based on target bleeding site for preve

Eligibility

Inclusion criteria

Inclusion criteria: • Subject is either male or female age 18 years or older at the time of study. • Subject or a legally authorized representative is willing to provide written Informed Consent by signing and dating the IRB or EC approved ICF. • Subject is a scheduled for surgical procedure. • Subject agrees to return for scheduled follow-up visits. • Haemoglobin (Hgb) >= 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).

Exclusion criteria

Exclusion criteria: •Subject with a known sensitivity to device materials. •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. •Subject or his/her legal authorized representative is unwilling or unable to sign the ICF. •Subject who, in consideration of treating doctor, would not be suitable for compliance of the follow-up. •Subject has a ruptured ectopic pregnancy. •Subject has a medical history of abnormal coagulopathy or uraemia. •Subject is currently enrolled in another study. •Subject currently using Anti-Coagulant medication including Coumadin, Plavix, etc. •Subject has prior radiation therapy treatment at the site. •Subject receiving an organ transplant during the same surgical procedure. •Life expectancy less than 12 months. •Current immunosuppressive therapy (more than 40 mg of corticoid per day or azathioprine).

Design outcomes

Primary

Measure	Time frame
Proportions of subjects achieving hemostasis at target bleeding sites. Timepoint: Time Frame: measure up to 10 mins after application	—

Secondary

Measure	Time frame
Absence of proven infection (No positive culture of blood results which indicate infection)Timepoint: Time Frame: within 30 days of initial surgery.;Postoperative MortalityTimepoint: Time Frame: 30 days after surgery	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Chief Gynecologist and Infertility Specialist- Dixit Hospital

ashatushardixit@gmail.com2603063880

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026