ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

NCT03912662 | Terminated Results

• 1 other identifier: MDT17048POETRY
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 11

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.

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• Incisional Hernia Rate

  Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.

  24 months

Secondary Outcomes (7)

• Adverse Event

  From the surgery to the 24-month visit

• Time to Incisional Hernia Occurrence

  From the surgery to the 24-month visit

• Post-operative Pain at the Site of Surgery

  Day 0, Day 1, Day 8, Month 1, Month 12, Month 24

• Quality of Life Questionnaire (QOL) for Patient

  Month 1, Month 12, Month 24

• Surgeon Satisfaction

  Day 0

Study Arms (1)

Hernia prevention cohort

OTHER

single arm safety study, no control arm

Device: Mesh augmented reinforcement

Interventions

Mesh augmented reinforcement DEVICE

Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh

Hernia prevention cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent.
• Subject is ≥ 18 years of age at the time of consent.
• Subject will be undergoing an elective midline laparotomy.
• 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:
• 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
• 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

You may not qualify if:

• Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
• Subject for which the device is used outside the product IFU, including;
• Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
• 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
• Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
• Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
• Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
• Subject has participated in an investigational drug or device research study within 30 days of enrollment.
• Subject has a life expectancy of \<2 years.
• Subject has an ASA Physical Status Classification System score \>3.
• Subject has \>5 total risk factors or \>2 high-risk factors

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (11)

CHU Besançon

Besançon, France

Location

CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Bordeaux, France

Location

CHU Lille

Lille, France

Location

HCL Louis Pradel

Lyon, France

Location

CHU de Nantes

Nantes, 44000, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU Hopitaux de Rouen

Rouen, France

Location

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Limitations and Caveats

Due to unsuccessful attempts to limit inclusion of complex patients with severe and multiple comorbidities at high risk of surgical complications that are not related to study device, and due to limited sample size, it was no longer feasible to clinically interpret the evidence from this study, leading to its early termination. Consequently, most planned analyses were not able to be performed. Limited data were collected, which affected the primary and secondary endpoint analyses.

Results Point of Contact

• Title: Marion Blanc
• Organization: Medtronic

marion.blanc@medtronic.com

+33 4 74 08 90 00

Study Officials

• Martin Bertrand, MD

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 11, 2019
• Study Start: September 18, 2019
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)