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ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

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ClinicalTrials.gov Identifier: NCT03912662
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Incisional Hernia Device: Mesh augmented reinforcement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Poetry Study - PrOGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Hernia prevention cohort Device: Mesh augmented reinforcement
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh




Primary Outcome Measures :
  1. Incisional hernia rate [ Time Frame: 24 months ]
    Occurence of incisional hernia assessed by clinical examination and abdominal CT scan


Secondary Outcome Measures :
  1. Adverse event [ Time Frame: From the surgery to the 24-month visit ]
    Adverse event incidence reported by number, severity, and relationship to the procedure and device

  2. Time to incisional hernia occurrence [ Time Frame: From the surgery to the 24-month visit ]
    Time to incisional hernia occurrence

  3. Post-operative pain at the site of surgery with Visual Analog Scale (VAS) [ Time Frame: 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.


  4. Quality of life questionnaire (QOL) for patient [ Time Frame: Month 12, Month 24 ]
    Assessment with Club Hernie registry QOL questionnaire of patient treated for suture line mesh reinforcement for long follow-up. Two sets of self-administered QOL and patient satisfaction questionnaire will be administered by phone call at 12 and 24 months.

  5. Quality of life questionnaire (QOL) for patient [ Time Frame: 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.

  6. Surgeon satisfaction [ Time Frame: Day 0 ]
    Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 has at least one of the following risk factors:

    • Obesity (BMI≥30)
    • Daily Active smokers
    • Chronic Obstructive Pulmonary disease (COPD)
    • Diabetes mellitus
    • Immunosuppression (organ transplant, chemotherapy, radiotherapy, corticosteroid treatment
    • Arteritis, Coronary Artery Disease,
    • Anti-coagulant treatment
    • Cirrhosis or Alcohol abuse
    • Aortic aneurism
    • Diastasis (>3cm) or Frail aponeurosis
    • Intestinal diverticulosis
    • Personal or familial history of groin or ventral hernias, or hiatal hernias
    • Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL
    • Dialysis

Exclusion Criteria:

  • 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
  • Subject who had received a mesh in a previous ventral hernia repair.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912662


Contacts
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Contact: Houria Belalit, MS +33 (0) 4 74 08 90 00 (#1381) houria.belalit@medtronic.com
Contact: Julie Pillat, PharmD +33 (0) 474 089 000 (#1527) julie.pillat@medtronic.com

Locations
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France
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Clinique Saint-Charles Not yet recruiting
La Roche-sur-Yon, France, 85016
CHU de Nantes Not yet recruiting
Nantes, France, 44000
CHU de Nîmes Not yet recruiting
Nîmes, France, 30029
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
CHU de Rennes - Hôpital Pontchaillou Not yet recruiting
Rennes, France, 35033
Centre Hospitalier Valenciennes Not yet recruiting
Valenciennes, France, 59322
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Michel Prudhomme, MD CHU de Nîmes

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03912662     History of Changes
Other Study ID Numbers: MDT17048POETRY
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes