Ventral HerniaNCT04986917
Laparoscopic Ventral Hernia Repair with Routine Defect Closure Using Su2ura® Approximation Device
A study testing Hernia repair surgery using the Su2ura® approximation device, Physical Examination and Vital Signs in people with Ventral Hernia, run by Anchora Medical at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Hernia repair surgery using the Su2ura® approximation device, Physical Examination and Vital Signs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesIsrael
- Study dates
- 19 Jan 2022to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria 1. Diagnosis of concomitant abdominal wall defect(s) contiguous with ventral hernia.
- 2. 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.
- 4. The patient desires hernia repair using a technique other than that consistent with the study.
- 5. 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.
- 8. 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.
- 18. Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily.
Show all 9Show fewer
- 19. Patient who is immunocompromised (including a diagnosis of HIV/AIDS, organ transplant, or receiving chemo- or radiation therapy.
- 20. Patient in need of concomitant surgical procedures other than indicated in the protocol as acceptable.
- 21. 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Barzilai Medical Center
Ashkelon, Southern District
Hillel Yaffe Medical Center
Hadera, Central District
About this 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 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.
Read more
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.
Read the detailed description
This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.
The study is a prospective, multi-center, open study, to evaluate the efficacy and safety of the Su2ura® approximation device.
An abdominal hernia emerges through a preformed or acquired defect of the abdominal wall. The defect may be congenital (primary), acquired as a result of wear and tear (primary), or result from surgery or trauma, where failure of the abdominal wall to heal produces an incisional (non-primary) hernia. Examples of abdominal hernia include epigastric, umbilical and inguinal hernia. Patients may be asymptomatic or complain of a lump or pain. These patients are offered elective surgery. Patients may also present with complications necessitating emergency repair with or without additional resection of compromised viscera.
Ventral hernias are very common and do present a challenge because of the risk of recurrence. Besides the surgeon, these hernias are ideally managed by a dietitian, nurse, and a physical therapist. Patient education has been a very popular topic in literature and hospital settings. Giving patients literature and discussing outcomes with instructions on multiple aspects throughout their encounters has shown to be very effective.
The Su2ura Approximation Device is designed to deploy anchors threaded with stiches to facilitate tissue approximation by eliminating the need for the passing of a needle from one side of the tissue to the other as performed in traditional suturing. Utilizing the anchor feature allows a single action placement of a suture.
The principal investigator from each medical center participated in an appropriate training program. This training included the surgery procedure in an animal. The Principal investigators will train the sub investigators in this procedure. The sponsor will also provide training on the laparoscopic simulator to the principal investigators.
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.
- Conditions
- Ventral Hernia
- Being tested
- Hernia repair surgery using the Su2ura® approximation device, Physical Examination, Vital Signs, Blood Tests, Urine Pregnancy Test
- Keywords
- hernia, primary, ventral, laparoscopy, umbilical
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia repair surgery using the Su2ura® approximation deviceDevice
Also called study device intervention
. 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.
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.
Vital SignsDiagnostic test
Vital signs include blood pressure, pulse, temperature, body weight and height, body mass index (BMI).
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.
Urine Pregnancy TestDiagnostic test
Urine pregnancy test will be performed during the screening visit (for WOCBP).
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.
EuraHS-QoLOther
Also called (hernia-specific European Hernia Society Quality of Life Questionnaire)
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
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.
Clinical evaluation for hernia recurrence and clinical bulgingDiagnostic test
The procedure includes:
- 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.
- SAE's and SADE's evaluation of the seroma.
- Taking a photograph of the surgery area without disclosing the subject's identity.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Hernia repair surgery using the Su2ura® approximation device; Diagnostic Test: Physical Examination; Diagnostic Test: Vital Signs; Diagnostic Test: Blood Tests; Diagnostic Test: Urine Pregnancy Test; Diagnostic Test: Abdominal Ultrasound imaging; Other: EuraHS-QoL; Other: Visual Analouge Scale (VAS); Diagnostic Test: Clinical evaluation for hernia recurrence and clinical bulging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Secondary outcomes (2)
Hernia recurrence rate
Hernia recurrence rate (Investigator confirmed hernia recurrence on physical examination or imaging).
Measured: up to 12 months
Patient satisfaction
- Patient satisfaction and function as assessed by the European Hernia Society Quality of life questionnaire (EuraHS-QoL). score range : 0-180 pts; higher score means high pain and discomfort levels.
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start19 Jan 2022
- Primary completion6 Aug 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anchora Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986917
- Sponsor's protocol ID
- ANC-002
- Status last verified
- Jan 2025
- First submitted
- 27 Jul 2021
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ventral Hernia Repair with Routine Defect Closure Using Su2ura® Approximation Device
- ClinicalTrials.gov ID
- NCT04986917
- Acronym / sponsor ID
- ANC-002
- Conditions
- Ventral Hernia
- Keywords
- hernia, primary, ventral, laparoscopy, umbilical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Anchora MedicalUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.
The study is a prospective, multi-center, open study, to evaluate the efficacy and safety of the Su2ura® approximation device.
An abdominal hernia emerges through a preformed or acquired defect of the abdominal wall. The defect may be congenital (primary), acquired as a result of wear and tear (primary), or result from surgery or trauma, where failure of the abdominal wall to heal produces an incisional (non-primary) hernia. Examples of abdominal hernia include epigastric, umbilical and inguinal hernia. Patients may be asymptomatic or complain of a lump or pain. These patients are offered elective surgery. Patients may also present with complications necessitating emergency repair with or without additional resection of compromised viscera.
Ventral hernias are very common and do present a challenge because of the risk of recurrence. Besides the surgeon, these hernias are ideally managed by a dietitian, nurse, and a physical therapist. Patient education has been a very popular topic in literature and hospital settings. Giving patients literature and discussing outcomes with instructions on multiple aspects throughout their encounters has shown to be very effective.
The Su2ura Approximation Device is designed to deploy anchors threaded with stiches to facilitate tissue approximation by eliminating the need for the passing of a needle from one side of the tissue to the other as performed in traditional suturing. Utilizing the anchor feature allows a single action placement of a suture.
The principal investigator from each medical center participated in an appropriate training program. This training included the surgery procedure in an animal. The Principal investigators will train the sub investigators in this procedure. The sponsor will also provide training on the laparoscopic simulator to the principal investigators.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Su2ura® approximation device - study device group | Experimental | Device: Hernia repair surgery using the Su2ura® approximation device, Diagnostic Test: Physical Examination, Diagnostic Test: Vital Signs, Diagnostic Test: Blood Tests, Diagnostic Test: Urine Pregnancy Test, Diagnostic Test: Abdominal Ultrasound imaging, Other: EuraHS-QoL, Other: Visual Analouge Scale (VAS), Diagnostic Test: Clinical evaluation for hernia recurrence and clinical bulgingPatients with a primary umbilical hernia will be recruited to the study and the hernia will be repaired using the Su2ura® approximation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Exclusion criteria 1. Diagnosis of concomitant abdominal wall defect(s) contiguous with ventral hernia.
- 2. 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.
- 4. The patient desires hernia repair using a technique other than that consistent with the study.
- 5. 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.
- 8. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hernia repair surgery using the Su2ura® approximation deviceAlso: study device intervention. 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. | Device | Su2ura® approximation device - study device group |
| Physical ExaminationAll 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. | Diagnostic test | Su2ura® approximation device - study device group |
| Vital SignsVital signs include blood pressure, pulse, temperature, body weight and height, body mass index (BMI). | Diagnostic test | Su2ura® approximation device - study device group |
| Blood TestsAll 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. | Diagnostic test | Su2ura® approximation device - study device group |
| Urine Pregnancy TestUrine pregnancy test will be performed during the screening visit (for WOCBP). | Diagnostic test | Su2ura® approximation device - study device group |
| Abdominal Ultrasound imagingAll subjects will undergo an abdominal ultrasound (US) imaging at 12 Months visit. The US will be performed to verify an absence of hernia recurrence. | Diagnostic test | Su2ura® approximation device - study device group |
| EuraHS-QoLAlso: (hernia-specific European Hernia Society Quality of Life Questionnaire)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 | Other | Su2ura® approximation device - study device group |
| Visual Analouge Scale (VAS)A validated, subjective measure measuring acute and chronic pain. questionnaire score range: 0-10; higher score indicates higher pain level. | Other | Su2ura® approximation device - study device group |
| Clinical evaluation for hernia recurrence and clinical bulgingThe 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. | Diagnostic test | Su2ura® approximation device - study device group |
Primary outcome
Adverse events assesments
Time frame: up to 30 days
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.
2 secondary outcomes
Hernia recurrence rate
Time frame: up to 12 months
Patient satisfaction
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hernia repair surgery using the Su2ura® approximation device, Physical Examination and Vital Signs in people with Ventral Hernia, run by Anchora Medical at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events assesments (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.