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TerminatedNCT03912662POETRYUpdated Dec 3, 2025Results posted

ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

An interventional study of Mesh augmented reinforcement in Incisional Hernia, sponsored by Medtronic - MITG. Terminated at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Medtronic - MITG · Not applicable, Interventional, and Treatment

Why this study was terminated
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.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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Conditions studied

  • Incisional Hernia

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03

In context

Incisional Hernia

219 studies on the registry are indexed under Incisional Hernia; 48 are open to participants now.

This study's enrollment of 32 is below the median of 108 across 137 interventional studies indexed under Incisional Hernia.

Browse Incisional Hernia studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Other
    Hernia prevention cohort

    single arm safety study, no control arm

    Device: Mesh augmented reinforcement

Interventions

  • DeviceMesh augmented reinforcement

    Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh

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What researchers measure

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.

    Time frame: 24 months

Secondary outcomes

  1. Adverse Event

    AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit

    Time frame: From the surgery to the 24-month visit

  2. Time to Incisional Hernia Occurrence

    Time to incisional hernia occurrence from the surgery to the 24-month visit

    Time frame: From the surgery to the 24-month visit

  3. 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).

    Time frame: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24

  4. 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.

    Time frame: Month 1, Month 12, Month 24

  5. Surgeon Satisfaction

    Surgeon satisfaction on mesh ease of use and manipulability.

    Time frame: Day 0

  6. Patient Satisfaction

    The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement.

    Time frame: Month 12, Month 24

  7. Surgeon Satisfaction

    Time to position the mesh

    Time frame: Day 0

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Results

Posted Dec 3, 2025
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.

Participant flow

Participant flow — Overall Study
MilestonePatients Consented for POETRY Study
Started35
Enrolled (received study device)32
Safety analysis set32
Completed6
Not completed29
Withdrew: Adverse event3
Withdrew: Adverse event and death1
Withdrew: Death1
Withdrew: Screen failure: subjects who provide study consent, but then were determined to be ineligible.1
Withdrew: Mesh removal1
Withdrew: Discontinued: eligible consented subjects who did not undergo the procedure with the study device.2
Withdrew: Early study termination20

Outcome measures

PrimaryIncisional Hernia Rate

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

Time frame:
24 months
Reported as:
Count of participants · Participants
Incisional Hernia Rate
ParticipantsPatients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up
Incisional Hernia Rate1
SecondaryAdverse Event

AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit

Time frame:
From the surgery to the 24-month visit
Reported as:
Number · Adverse Events
Adverse Event
Adverse EventsPatients Treated With ProGrip™ Self-Gripping Polyester Mesh
Total Number of Adverse Events39
Number of SAEs25
Number of non-Serious AEs14
Number of Device-Related AEs8
Number of Mesh Placement Procedure-related AEs5
Number of Device-related SAEs6
Number of Mesh Placement Procedure-related SAEs3
Number of Index Procedure related AEs27
Number of Index Procedure related SAEs14
Number of AEs with action taken38
AEs by reason for Seriousness: Hospitalization18
AEs by reason for Seriousness: Death2
AEs by reason for Seriousness: Life threatening illness or injury8
AEs by reason for Seriousness: Permanent impairment of a body structure or body function1
AEs by reason for Seriousness: Medical or surgical intervention19
AEs by Relation to Study Device: Not Related31
AEs by Relation to Study Device: Related8
AEs by Relation to Index Procedure: Not Related12
AEs by Relation to Index Procedure: Related27
AEs by Relation to Mesh Placement Procedure: Not Related24
AEs by Relation to Mesh Placement Procedure: Related4
SecondaryTime to Incisional Hernia Occurrence

Time to incisional hernia occurrence from the surgery to the 24-month visit

Time frame:
From the surgery to the 24-month visit
Reported as:
Median · Days to hernia occurrence
Time to Incisional Hernia Occurrence
Days to hernia occurrencePatients Treated With ProGrip Self- Gripping Polyester Mesh
Time to Incisional Hernia Occurrence384 (384 to 384)
SecondaryPost-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).

Time frame:
Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
Reported as:
Mean · score on a scale of 0-10
Post-operative Pain at the Site of Surgery
score on a scale of 0-10Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
EVA (VAS) Day 03.8 ± 2.94
EVA (VAS) Day 13.7 ± 2.73
EVA (VAS) Day 81.9 ± 2.42
EVA (VAS) Month 10.4 ± 0.91
EVA (VAS) Month 120.5 ± 1.81
EVA (VAS) Month 240 ± 0
SecondaryQuality 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.

Time frame:
Month 1, Month 12, Month 24
Reported as:
Number · participants
Quality of Life Questionnaire (QOL) for Patient
participantsPatients Treated With ProGrip™ Self-Gripping Polyester Mesh
Month 1 : Post-operative discomfort: No symptoms16
Month 1 : Post-operative discomfort: Discomfort3
Month 1: Post-operative discomfort: Tingling (dyesthesia, hyperesthesia, hyperpathia)1
Month 1: Post-operative discomfort: Reduced sensitivity3
Month 1: Post-operative discomfort: Moderated pain per Visual Analog Scale (VAS)3
Month 1: Post-operative discomfort: Other symptoms3
Month 1: Post-operative discomfort: Response missing8
Month 12 : Post-operative discomfort: No symptoms14
Month 12: Post-operative discomfort: Significant pain1
Month 12: Post-operative discomfort: Other symptoms1
Month 24 : Post-operative discomfort: No symptoms3
Month 24: Post-operative discomfort: Reduced sensitivity1
Month 1: Location of symptoms: Not applicable17
Month 1: Location of symptoms: Side operated on6
Month 1: Location of symptoms: Contralateral2
Month 1: Location of symptoms: Elsewhere2
Month 1: Location of symptoms: Response missing7
Month 1: Timing of symptoms: Not applicable19
Month 1: Timing of symptoms: after exertion or end of day3
Month 1: Timing of symptoms: Anytime2
Month 1: Timing of symptoms: During other activities2
Month 1: Timing of symptoms: Response missing7
Month 1: Frequency of symptoms: Not applicable19
Month 1: Frequency of symptoms: Several times per day1
Month 1: Frequency of symptoms: Often during day3
Month 1: Frequency of symptoms: All day1
Month 1: Frequency of symptoms: 24 hours a day1
Month 1: Frequency of symptoms: Response missing7
Month 1: Impact of symptoms on activities: Not applicable19
Month 1: Impact of symptoms on activities: prohibits certain activities3
Month 1: Impact of symptoms on activities: temporary stop of activities2
Month 1: Impact of symptoms on activities: continue activities1
Month 1: Impact of symptoms on activities: response missing7
Month 1: pre- and post-operative pain: Not applicable21
Month 1: pre- and post-operative pain: post-operative discomfort < Hernia discomfort3
Month 1: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort1
Month 1: pre- and post-operative pain: response missing7
Month 12: Location of symptoms: Not applicable15
Month 12: Location of symptoms: Elsewhere1
Month 12: Timing of symptoms: Not applicable15
Month 12: Timing of symptoms: After exertion or end of day1
Month 12: Frequency of symptoms: Not applicable15
Month 12: Frequency of symptoms: Often during day1
Month 12: Impact of symptoms on activities: Not applicable15
Month 12: Impact of symptoms on activities: Prohibits certain activities1
Month 12: pre- and post-operative pain: Not applicable14
Month 12: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort1
Month 12: pre- and post-operative pain: Response missing1
Month 24: Location of symptoms: Not applicable3
Month 24: Location of symptoms: Bilateral1
Month 24: Timing of symptoms: Not applicable3
Month 24: Timing of symptoms: Anytime1
Month 24: Frequency of symptoms: Not applicable4
Month 24: Impact of symptoms on activities: Not applicable3
Month 24: Impact of symptoms on activities: Does not disrupt activities1
Month 24: pre- and post-operative pain: Not applicable3
Month 24: pre- and post-operative pain: post-operative discomfort < Hernia discomfort1
Month 12: Perception of structure of abdominal wall: Solid16
Month 12: Perception of lump in abdominal wall: No15
Month 12: Perception of lump in abdominal wall: Elsewhere1
Month 24: Perception of structure of abdominal wall: Solid4
Month 24: Perception of lump in abdominal wall: No4
SecondarySurgeon Satisfaction

Surgeon satisfaction on mesh ease of use and manipulability.

Time frame:
Day 0
Reported as:
Number · surgeons
Surgeon Satisfaction
surgeonsSurgeons Placing ProGrip™ Self-Gripping Polyester Mesh
Flexibility of the Mesh : Satisfactory25
Flexibility of the Mesh : Not Stated1
Cuttable : Satisfactory24
Cuttable : Not Stated2
Mesh shape memory : Satisfactory24
Mesh shape memory : Unsatisfactory1
Mesh shape memory : Not Stated1
Mesh placement - adhesion to the wall17
Mesh placement - absence of laying direction8
Mesh placement - shape memory5
Mesh placement - transparency8
Mesh placement - easy to reposition12
SecondaryPatient Satisfaction

The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement.

Time frame:
Month 12, Month 24
Reported as:
Number · participants
Patient Satisfaction
participantsPatients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
Month 12: Repeat Procedure Performed = No14
Month 12: Repeat Procedure Performed = Response Missing2
Month 12: Strength of abdominal wall = Excellent5
Month 12: Strength of abdominal wall = Good5
Month 12: Strength of abdominal wall = Moderate1
Month 12: Strength of abdominal wall = Poor1
Month 12: Strength of abdominal wall = response missing4
Month 24: Repeat Procedure Performed = No4
Month 24: Strength of abdominal wall = Excellent1
Month 24: Strength of abdominal wall = Good3
Month 24: Strength of abdominal wall = Poor0
SecondarySurgeon Satisfaction

Time to position the mesh

Time frame:
Day 0
Reported as:
Mean · minutes
Surgeon Satisfaction
minutesSurgeons Placing ProGrip™ Self-Gripping Polyester Mesh
Surgeon Satisfaction8.0 ± 6.34

Adverse events

Collected over surgery to the 24-month visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patients Treated With ProGrip™ Self-Gripping Polyester Mesh2/32 (6.3%)10/32 (31.3%)17/32 (53.1%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventPatients Treated With ProGrip™ Self-Gripping Polyester Mesh
Wound eviscerationInjury, poisoning and procedural complications2/32
Acute kidney injuryRenal and urinary disorders2/32
ArrhythmiaCardiac disorders1/32
Gastrointestinal fistulaGastrointestinal disorders1/32
Gastrointestinal ischaemiaGastrointestinal disorders1/32
IleusGastrointestinal disorders1/32
Intra-abdominal fluid collectionGastrointestinal disorders1/32
Oesophageal ulcerGastrointestinal disorders1/32
Pancreatitis acuteGastrointestinal disorders1/32
Multiple organ dysfunction syndromeGeneral disorders1/32
Most frequent other events
Showing 10 of 35
Most frequent other events
EventPatients Treated With ProGrip™ Self-Gripping Polyester Mesh
DiarrhoeaGastrointestinal disorders2/32
SeromaInjury, poisoning and procedural complications2/32
Wound eviscerationInjury, poisoning and procedural complications2/32
Acute kidney injuryRenal and urinary disorders2/32
ArrhythmiaCardiac disorders1/32
Fistula of small intestineGastrointestinal disorders1/32
Gastrointestinal fistulaGastrointestinal disorders1/32
Gastrointestinal ischaemiaGastrointestinal disorders1/32
IleusGastrointestinal disorders1/32
Impaired gastric emptyingGastrointestinal disorders1/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Mean69.1 ± 13.19
Sex: Female, Male
Sex: Female, Male(Participants)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Female13
Male19
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Weight
Weight(kg)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Mean73.6 ± 17.96
Height
Height(cm)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Mean169.5 ± 9.26
BMI
BMI(kg/m^2)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Mean25.5 ± 5.66
Work
Work(Participants)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Unemployed16
Administrative work4
Moderately physical labor5
Physical labor3
Not Provided4
Sport Activity
Sport Activity(Participants)Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
None14
Intense (>1x/week)3
Moderate (1x/week)14
Sporadic1
08

Study locations

11 sites
  • CHU Besançon
    Besançon, France
  • CHU de Bordeaux
    Bordeaux, 33076, France
  • CHU de Bordeaux - Hôpital Haut-Lévêque
    Bordeaux, France
  • CHU Lille
    Lille, France
  • HCL Louis Pradel
    Lyon, France
  • CHU de Nantes
    Nantes, 44000, France
  • CHU de Nîmes
    Nîmes, 30029, France
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69310, France
  • CHU de Rennes - Hôpital Pontchaillou
    Rennes, 35033, France
  • CHU Hopitaux de Rouen
    Rouen, France
  • CHU Strasbourg - Nouvel Hôpital Civil
    Strasbourg, 67000, France
09

References and documents

Study documents

  • Study protocol · Sep 25, 2020
  • Statistical analysis plan · Nov 5, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03912662
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Apr 11, 2019
Start date
Sep 18, 2019
Primary completion
Sep 12, 2022
Completion
Sep 12, 2022
Results posted
Dec 3, 2025
Last update
Dec 3, 2025

Study contacts

Martin Bertrand, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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