Incisional HerniaPOETRYNCT03912662
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
A study testing Mesh augmented reinforcement in people with Incisional Hernia, run by Medtronic - MITG at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Mesh augmented reinforcement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 11 sitesFrance
- Study dates
- 18 Sep 2019to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Besançon
Besançon
CHU de Bordeaux
Bordeaux, 33076
CHU de Bordeaux - Hôpital Haut-Lévêque
Bordeaux
CHU Lille
Lille
HCL Louis Pradel
Lyon
CHU de Nantes
Nantes, 44000
CHU de Nîmes
Nîmes, 30029
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
CHU Hopitaux de Rouen
Rouen
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67000
About this study
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
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.
Read the 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.
- Conditions
- Incisional Hernia
- Being tested
- Mesh augmented reinforcement
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh augmented reinforcementDevice
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
| Study group | Role | What they receive |
|---|---|---|
| Hernia prevention cohort | Other | single arm safety study, no control arm Receives: Device: Mesh augmented reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Hernia Rate
Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.
Measured: 24 months
Secondary outcomes (7)
Adverse Event
AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit
Measured: From the surgery to the 24-month visit
Time to Incisional Hernia Occurrence
Time to incisional hernia occurrence from the surgery to the 24-month visit
Measured: From the surgery to the 24-month visit
Post-operative Pain at the Site of Surgery
Post-operative pain at the site of the surgery was measured at days 0, 1, 8 and months 1, 12, 24 using a Visual Analog Scale - a psychometric response scale (0-10) (0 no pain, 10 the worst) either during systematic clinical visit or by phone call when a subject is already discharged. (Worst pain experienced over the last 24 hours).
Measured: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
Quality of Life Questionnaire (QOL) for Patient
Assessment with Club Hernie Registry QOL questionnaire of patients treated with ProGrip Self-Gripping Polyester Mesh for suture line mesh reinforcement. . Two sets of self-administered QOL were administered; one for 1 month and one for 12- and 24-month.
Measured: Month 1, Month 12, Month 24
Surgeon Satisfaction
Surgeon satisfaction on mesh ease of use and manipulability.
Measured: Day 0
Patient Satisfaction
The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement.
Measured: Month 12, Month 24
Surgeon Satisfaction
Time to position the mesh
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start18 Sep 2019
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Why it stopped: Surgical complications arose early in the study, mainly due to patient complexity, not to study device or implantation. Despite refining protocol to exclude highly complex patients, these issues persisted, leading to the study's early termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Incisional 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Bertrand, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912662
- Sponsor's protocol ID
- MDT17048POETRY
- Acronym
- POETRY
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2019
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03912662
- Acronym / sponsor ID
- POETRY / MDT17048POETRY
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgical complications arose early in the study, mainly due to patient complexity, not to study device or implantation. Despite refining protocol to exclude highly complex patients, these issues persisted, leading to the study's early termination.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hernia prevention cohort | Other | Device: Mesh augmented reinforcementsingle arm safety study, no control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (11 listed)
- 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;
- 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.
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 |
|---|---|---|
| Mesh augmented reinforcementAbdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh | Device | Hernia prevention cohort |
Primary outcome
Incisional Hernia Rate
Time frame: 24 months
Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.
7 secondary outcomes
Adverse Event
Time frame: From the surgery to the 24-month visit
Time to Incisional Hernia Occurrence
Time frame: From the surgery to the 24-month visit
Post-operative Pain at the Site of Surgery
Time frame: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
Quality of Life Questionnaire (QOL) for Patient
Time frame: Month 1, Month 12, Month 24
Surgeon Satisfaction
Time frame: Day 0
Patient Satisfaction
Time frame: Month 12, Month 24
Surgeon Satisfaction
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Martin Bertrand, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh augmented reinforcement in people with Incisional Hernia, run by Medtronic - MITG at 11 sites in France.
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 11 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: stopped early, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incisional Hernia Rate (time frame: 24 months). 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 3 Dec 2025.