MedTrace Logo

Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device

NCT04393532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-01-22

No results posted yet for this study

Summary

Intended Use The Su2ura™ Approximation Device is indicated for tissue approximation in endoscopic and open surgery for the placement of interrupted or running stitches in soft tissue such as hernia repair

Objectives To assess the safety and efficacy of the Su2ura approximation device for the laparoscopic repair of primary umbilical hernia

Number of Subjects 45 patients

Number of Centers Two study centers in Israel and one in Slovenia.

Study Duration 6 months

Study Procedures Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered at induction of anesthesia. A single surgeon, the PI, will perform the procedure. A surgical assistant will be selected by the PI from the surgical staff of the department.

The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura approximation device and fixation of mesh with tacks over the closed defect.

Study follow up visits: at post operation discharge, 14 days, 3 months, 6 months.

Study follow up procedures:

Also include SAE's and SADE's during follow up

1. Quality of life questionnaire: patient-reported satisfaction and function will be assessed through the validated, hernia-specific European Hernia Society Quality of Life questionnaire (EuraHS-QoL)
2. Clinical testing to determine hernia recurrence and clinical bulging

Statistical analysis The sample size calculation based on the Exact Binomial distribution. The investigators will compute the 95% confidence intervals for a binomial probability, relying on the Clopper-Pearson (exact) method.

Conditions

  • Primary Umbilical Hernia

Interventions

DEVICE

Su2ura Approximation Device

the use of the study device during a laparoscopic surgery

PROCEDURE

Laparoscopic hernia repair surgery

repairing primary umbilical hernia in a laparoscopic procedure using the study device.

Sponsors & Collaborators

  • Anchora Medical

    lead OTHER

Principal Investigators

  • Yoni Epstein · Anchora Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-23
Primary Completion
2024-01-28
Completion
2024-04-18

Countries

  • Israel
  • Slovenia

Study Locations

More Related Trials

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 NCT04393532 on ClinicalTrials.gov