NCT04986917

Brief Summary

Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12 months post-surgery. Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered 30 min prior to skin incision. 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 in an IPOM fashion. Based on surgeon consideration, primary umbilical hernia defects under 2 cm will be repaired with or without mesh. Study follow-up visits will take place 14 days, 3 months and 12 months post-surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2024

Completed
Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

July 27, 2021

Last Update Submit

January 20, 2025

Conditions

Ventral Hernia

Keywords

herniaprimaryventrallaparoscopyumbilical

Outcome Measures

Primary Outcomes (1)

  • Adverse events assesments

    Overall rate of Serious Adverse Events and serious adverse device effects (SADE) related to study product up to hospital discharge and up to the 30th post-operative day.

    up to 30 days

Secondary Outcomes (2)

  • Hernia recurrence rate

    up to 12 months

  • Patient satisfaction

    up to 14 days

Study Arms (1)

Su2ura® approximation device - study device group

EXPERIMENTAL

Patients with a primary umbilical hernia will be recruited to the study and the hernia will be repaired using the Su2ura® approximation device

Device: Hernia repair surgery using the Su2ura® approximation deviceDiagnostic Test: Physical ExaminationDiagnostic Test: Vital SignsDiagnostic Test: Blood TestsDiagnostic Test: Urine Pregnancy TestDiagnostic Test: Abdominal Ultrasound imagingOther: EuraHS-QoLOther: Visual Analouge Scale (VAS)Diagnostic Test: Clinical evaluation for hernia recurrence and clinical bulging

Interventions

Hernia repair surgery using the Su2ura® approximation deviceDEVICE

. The hernia defect will be measured and the Su2ura® approximation device will then be used to close the defect, placing stainless steel implantable anchors threaded on a Polyethylene braided surgical suture.

Also known as: study device intervention
Su2ura® approximation device - study device group
Physical ExaminationDIAGNOSTIC_TEST

All subjects will undergo a standard physical examination by an authorized physician. The physician's evaluation will include diagnosis and documentation of any significant clinical abnormalities or diseases.

Su2ura® approximation device - study device group
Vital SignsDIAGNOSTIC_TEST

Vital signs include blood pressure, pulse, temperature, body weight and height, body mass index (BMI).

Su2ura® approximation device - study device group
Blood TestsDIAGNOSTIC_TEST

All subjects will undergo Hematology and Biochemistry blood tests. Blood Hematology test will include a complete CBC. Blood Biochemistry test will include the following measures: Sodium (Na), Potassium (K), Chloride (Cl), Creatinine, Glucose, Urea, Albumin, Calcium total, Alkaline Phosphatase (ALP), ALT, AST, Total Bilirubin, Direct Bilirubin, LDH, Total Protein, Uric Acid, CRP, and Lipid Profile (including Total Cholesterol, HDL, LDL, Triglycerides). 5 ml of blood (equals to 1 spoon) will be taken for each test.

Su2ura® approximation device - study device group
Urine Pregnancy TestDIAGNOSTIC_TEST

Urine pregnancy test will be performed during the screening visit (for WOCBP).

Su2ura® approximation device - study device group
Abdominal Ultrasound imagingDIAGNOSTIC_TEST

All subjects will undergo an abdominal ultrasound (US) imaging at 12 Months visit. The US will be performed to verify an absence of hernia recurrence.

Su2ura® approximation device - study device group
EuraHS-QoLOTHER

patients will be asked to fill a questionnaire assessing patient-reported satisfaction and function. questionnaire score range: 0-180; higher score indicates higher pain and discomfort

Also known as: (hernia-specific European Hernia Society Quality of Life Questionnaire)
Su2ura® approximation device - study device group
Visual Analouge Scale (VAS)OTHER

A validated, subjective measure measuring acute and chronic pain. questionnaire score range: 0-10; higher score indicates higher pain level.

Su2ura® approximation device - study device group
Clinical evaluation for hernia recurrence and clinical bulgingDIAGNOSTIC_TEST

The procedure includes: 1. Clinical examination to determine the presence of hernia recurrence and clinical bulging, in an inconclusive physical exam a radiological imaging will be performed such as US or CT. 2. SAE's and SADE's evaluation of the seroma. 3. Taking a photograph of the surgery area without disclosing the subject's identity.

Su2ura® approximation device - study device group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Patient desires an elective surgical repair.
  • Patient is able to provide an informed consent.
  • Diagnosis of a primary or secondary ventral hernia, with a fascial defect of width no more than 5 cm width in size on clinical examination or imaging scan.
  • Body mass index (BMI) of 20-40 kg/m2.
  • Candidate for laparoscopic repair based on the operating surgeon's assessment.

You may not qualify if:

  • \. Patient in need of concomitant non-hernia repair surgical procedure(s). 3. Patient in need of emergent ventral hernia repair for complications such as incarceration, intestinal obstruction or strangulation.
  • \. The patient desires hernia repair using a technique other than that consistent with the study.
  • \. Patient has loss of domain as assessed on physical examination or CT scan. 6. Patient has a history of an abdominal aortic aneurysm repair. 7. Patient has a severe co-morbid condition likely to limit survival to less than 2 years.
  • \. Patient was treated with chemotherapy in the past 6 months. 9. Patient was treated with steroids in the past 6 months. 10. Patient with known collagen disorder. 11. Clean contaminated/contaminated or dirty surgical field. 12. Patient is pregnant or intends to become pregnant during the study period. 13. Patient has ascites on physical examination or CT scan. 14. Patient has liver failure. 15. Patient undergoing dialysis treatment. 16. Patient has a wound-healing disorder. 17. Patient has an untreated coagulation disorder or is on anti-coagulant therapy not managed peri-operatively with the advice or supervision of a hematologist.
  • \. Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily.
  • \. Patient who is immunocompromised (including a diagnosis of HIV/AIDS, organ transplant, or receiving chemo- or radiation therapy.
  • \. Patient in need of concomitant surgical procedures other than indicated in the protocol as acceptable.
  • \. Non-compliance with the study protocol. 22. Patient requests to exit the study. 23. Prior radiotherapy. 24. Active malignancy for at least 2 years. 25. Patients has Diastasis recti more than 4cm×4cm size

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hillel Yaffe Medical Center

Hadera, Central District, Israel

Location

Barzilai Medical Center

Ashkelon, Southern District, Israel

Location

MeSH Terms

Conditions

Hernia, VentralHernia

Interventions

Physical ExaminationVital SignsHematologic Tests

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisClinical Laboratory TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A total of 60 patients will be recruited to the study. Patients with a primary umbilical hernia under 2 cm will be recruited to the study and the hernia will be repaired with or without mesh according to the PI's decision. Eligible patients with a primary or secondary ventral hernia, desiring an elective surgical repair, who amply the inclusion/Exclusion criteria will be offered to participate in the study. Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12months post-surgery.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 3, 2021

Study Start

January 19, 2022

Primary Completion

August 6, 2024

Study Completion

November 21, 2024

Last Updated

January 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)