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Clinical Trials in South Korea / NCT06709170
Starting soon Not applicable

Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study

NCT06709170 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2025-03-01
Last updated
2024-11-29

Condition(s) studied

Colo-rectal Cancer

Investigational drug(s) / intervention(s)

Novel asymmetrical linear staplerSignia™

Novel asymmetrical linear stapler: Novel asymmetrical linear stapler

Signia™: Signia™

Study summary

Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length \>1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.

Eligibility

Sex
ALL
Min age
19 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: * Rectal cancer patients between the age of 19\~79, who require anus preserving laparoscopic rectum resection surgery Exclusion Criteria: * Advanced rectal cancer that invades surrounding structures or has known distant metastasis * Uncontrolled comorbidities * Patients otherwise considered unsuitable for the study

Primary outcome measure(s)

  • True distal margin length > 1cm — Intraoperative
    True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Jongro-gu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06709170 on ClinicalTrials.gov ↗ ← All trials in South Korea