ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

Not Applicable

Terminated

• Conditions: Incisional Hernia
• Interventions: Device: Mesh augmented reinforcement

• Registration Number: NCT03912662
• Lead Sponsor: Medtronic - MITG

Brief Summary

Interventional, prospective, multicenter, post-marketing clinical follow-up study.

After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health.

As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.

Detailed Description

The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects undergoing procedures with midline laparotomies.

Secondary Objective The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGrip™ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Study Start: 2019-09-18
• Primary Completion: 2022-09-06
• Study Completion: 2022-09-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Subject has provided informed consent.

2. Subject is ≥ 18 years of age at the time of consent.

3. Subject will be undergoing an elective midline laparotomy.

4. Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:

   1. High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism
   2. Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI < 35; ii.Age > 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery

Exclusion Criteria

1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.

2. Subject for which the device is used outside the product IFU, including;

   1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
   2. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
   3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).

3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.

4. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.

5. Subject has participated in an investigational drug or device research study within 30 days of enrollment.

6. Subject has a life expectancy of <2 years.

7. Subject has an ASA Physical Status Classification System score >3.

8. Subject has >5 total risk factors or >2 high-risk factors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hernia prevention cohort	Mesh augmented reinforcement	single arm safety study, no control arm

Primary Outcome Measures

Name	Time	Method
Incisional hernia rate	24 months	Occurence of incisional hernia assessed by clinical examination and abdominal CT scan

Secondary Outcome Measures

Name	Time	Method
Adverse event	From the surgery to the 24-month visit	Adverse event incidence reported by number, severity, and relationship to the procedure and device
Surgeon satisfaction	Day 0	Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.
Time to incisional hernia occurrence	From the surgery to the 24-month visit	Time to incisional hernia occurrence
Post-operative pain at the site of surgery with Visual Analog Scale (VAS)	Day 0, Day 1, Day 8, Month 1, Month 12, Month 24	Assessment of post-operative pain using a 0 to 10 Visual Analogic Scale. Worst pain experienced over the last 24 hours.; Mild pain for VAS score between 0 and 3. Moderate pain for VAS score \>3 and ≤6. Severe pain for VAS score \>6.
Quality of life questionnaire (QOL) for patient	Month 1	Assessment with Club Hernie registry QOL questionnaire of patient treated for suture line mesh reinforcement for long follow-up. A self-administered QOL questionnaire will be administered at 1 month.

Trial Locations

Locations (11)

CHU Besançon; 🇫🇷 Besançon, France

CHU Hopitaux de Rouen; 🇫🇷 Rouen, France

HCL Louis Pradel; 🇫🇷 Lyon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nîmes; 🇫🇷 Nîmes, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

CHU de Rennes - Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHU Strasbourg - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

CHU de Bordeaux - Hôpital Haut-Lévêque; 🇫🇷 Bordeaux, France

CHU Lille; 🇫🇷 Lille, France