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Device Development for a Diagnostic Procedure in Liver Diseases

Development of a Device for Performing Biopsy Video-Assisted Liver

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4n6rqyj
Enrollment
Unknown
Registered
2023-02-02
Start date
2019-01-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Liver Cirrhosis

Interventions

This is a two-arm, randomized, controlled clinical trial without cagamete. Experimental group: 12 patients with an ultrasound finding of moderate to severe hepatic steatosis will receive a needle biop

Sponsors

Instituto para O Desenvolvimento da Educação Ltda.
Lead Sponsor
Instituto para O Desenvolvimento da Educação Ltda.
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with moderate to severe hepatic steatosis, submitted to abdominal laparoscopic surgery for another underlying disease; Patients who needed a liver biopsy for etiological confirmation or staging of disease activity

Exclusion criteria

Exclusion criteria: Refusal to participate in the study: Patients diagnosed with hepatocellular carcinoma (HCC) AND The following risk factors: Patients with INR > 1.8 and/or platelets < 70,000/mm3; Patients diagnosed with hepatocellular carcinoma (HCC); Patients with coagulopathy

Design outcomes

Primary

MeasureTime frame
Expected outcome: 44% reduction in painful symptoms and bleeding.;Outcome reached: 44% reduction in painful symptoms and bleeding.

Secondary

MeasureTime frame
No secondary outcomes planned.

Countries

Brazil

Contacts

Public ContactAlexandre Mano

IPADE - Instituto para o Desenvolvimento da Educação Ltda.

hermano@ufc.br+55 (85) 3366-8044

Outcome results

None listed

Source: REBEC (via WHO ICTRP)