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Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.

NCT06286540 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-03-15

No results posted yet for this study

Summary

Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.

Conditions

  • Aorta Abdominalis; Aneurysm
  • Aorta Thoracic; Aneurysm

Interventions

DEVICE

Lymphoblock

1 time per surgery with the exposition for 20 minutes.

DEVICE

Placebo

1 time per surgery with the exposition for 20 minutes.

Sponsors & Collaborators

  • Petrovsky National Research Centre of Surgery

    lead OTHER

Principal Investigators

  • Eduard Charchyan, MD · Petrovsky NRCS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2026-02-28
Completion
2026-05-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286540 on ClinicalTrials.gov