- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03912662
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention (POETRY)
Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Besançon, France
- CHU Besançon
-
Bordeaux, France, 33076
- CHU de Bordeaux
-
Bordeaux, France
- CHU de Bordeaux - Hôpital Haut-Leveque
-
Lille, France
- CHU Lille
-
Lyon, France
- HCL Louis Pradel
-
Nantes, France, 44000
- CHU de Nantes
-
Nîmes, France, 30029
- CHU de Nimes
-
Pierre-Bénite, France, 69310
- Centre Hospitalier Lyon Sud
-
Rennes, France, 35033
- CHU de Rennes - Hôpital Pontchaillou
-
Rouen, France
- CHU Hôpitaux de Rouen
-
Strasbourg, France, 67000
- CHU Strasbourg - Nouvel Hopital Civil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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
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, 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Hernia prevention cohort
single arm safety study, no control arm
|
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incisional hernia rate
Time Frame: 24 months
|
Occurence of incisional hernia assessed by clinical examination and abdominal CT scan
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From the surgery to the 24-month visit
|
Time to incisional hernia occurrence
Time Frame: 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 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. |
Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
|
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.
|
Month 12, Month 24
|
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.
|
Month 1
|
Surgeon satisfaction
Time Frame: Day 0
|
Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.
|
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Bertrand, MD, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT17048POETRY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Incisional Hernia
-
W.L.Gore & AssociatesRecruitingHernia, Ventral | Hernia Incisional | Hernia Incisional VentralUnited States, Spain, Italy, United Kingdom
-
Zagazig UniversityCompletedIncisional Hernia of Midline of Abdomen | Incisional Hernia of Midline of Upper Abdomen | Incisional Hernia of Midline of Lower AbdomenEgypt
-
Mansoura UniversityUnknownHernia, Abdominal | Hernia, Ventral | Hernia IncisionalEgypt
-
C. R. BardCompletedHernia | Hernia, Abdominal | Hernia, IncisionalBelgium, Netherlands, Denmark, France, Italy, United Kingdom, Austria, Germany
-
Hospital Central "Dr. Ignacio Morones Prieto"UnknownHernia, Ventral | Ventral Incisional Hernia
-
Universitaire Ziekenhuizen KU LeuvenBelgian Section for Abdominal Wall Surgery, section of the Royal Belgian...Not yet recruitingVentral Incisional Hernia
-
University of PennsylvaniaCompleted
-
Azienda Sanitaria Locale Napoli 2 NordCompletedHernia, Abdominal | Hernia IncisionalItaly
-
Medtronic - MITGCompletedVentral Incisional HerniaFrance
-
Hospital Regional de Alta Especialidad del BajioCompleted
Clinical Trials on Mesh augmented reinforcement
-
Hospital Regional de Alta Especialidad del BajioCompleted
-
Karolinska InstitutetStockholm South General HospitalRecruiting
-
Zagazig UniversityCompletedIncisional Hernia | Midline Incisions | High Risk Patients | Mesh Reinforcement
-
Hospices Civils de LyonRecruiting
-
Saint Petersburg State University, RussiaActive, not recruiting
-
Mayo ClinicCompleted
-
University of Campania "Luigi Vanvitelli"CompletedIncisional Hernia
-
W.L.Gore & AssociatesCompletedVentral Incisional HerniaUnited States, Netherlands
-
Washington University School of MedicineTerminated
-
Hospital Universitari Vall d'Hebron Research InstituteUnknown