Inguinal HerniaNCT05306496
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
A study testing Pre-shaped 4DMESH® in people with Inguinal Hernia and Femoral Hernia, run by Cousin Biotech at 9 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Femoral Hernia
- What is being tested?
- Pre-shaped 4DMESH®
- Type of treatment
- Medical device
- How many people
- 196 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 30 Jun 2022to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
- Patients with American Society of Anesthesiologists (ASA) grade I to III.
- Patient ≥ 18 years of age at study entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
Who cannot join
- Patient has a recurrent inguinal or femoral hernia.
- Patient is treated using the Lichtenstein technique.
- Patients with ASA grade IV and V.
- Patient is allergic to the components of the 4DMESH®.
- Presence of an infected site.
- Patient has a life expectancy of less than 5 years.
Show all 12Show fewer
- Patient is unable / unwilling to provide informed consent.
- Patient is unable to comply with the protocol or proposed follow-up visits.
- Patient is enrolled in another study (BE/ES) / Participation in a clinical trial within 3 months prior to the initial visit (FR).
- Patient is pregnant (BE/FR) / Pregnant women (ES).
- Patient benefiting from a legal protection measure (minors, under guardianship, curatorship, safeguard of justice, future protection mandate or family empowerment) (FR).
- Patient not benefiting from a social protection scheme (FR).
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France4 sites
Hôpital Lyon Sud, Hospices Civils de Lyon
Lyon, 69002
CHU de Nantes
Nantes, 44093
CHU de Reims
Reims, 51092
CH de Tourcoing
Tourcoing, 59208
Belgium3 sites
Ziekenhuis Oost-Limburg Genk
Genk, Limburg, 3600
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Vlaams-Brabant, 3300
Spain2 sites
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Viamed Santa Ángela de la Cruz en Sevilla
Seville, 41014
About this study
Official title: Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
- Conditions
- Inguinal Hernia, Femoral Hernia
- Being tested
- Pre-shaped 4DMESH®
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-shaped 4DMESH®Device
The 4DMESH® mesh is semi-resorbable parietal reinforcement implant made of 25% Polypropylene (non-resorbable) and 75% Poly-L-Lactic Acid (resorbable). 4DMESH® meshes are designed for the repair and reinforcement of inguinal and femoral hernias. 4DMesh is a CE-marked, class III medical device manufactured by Cousin Biotech.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.
Measured: At 12-months follow-up
Secondary outcomes (44)
Technical success
To determine the percentage of procedures with technical success, defined as (robot-assisted) laparoscopic TEP or TAPP as intended without technical difficulties and without conversion to open laparotomy.
Measured: At index-procedure
Duration of surgery
To determine the mean duration of the surgery.
Measured: At index-procedure
Duration of hospital stay
To determine the mean duration of hospital stay.
Measured: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
Peri- and post-operative complications related to 4DMESH®
To determine the rate of peri- and post-operative complications related to 4DMESH® up to 5-years follow-up.
Measured: At 5-years follow-up
Early recurrences
To determine the early recurrence rate at 4-5 weeks follow-up.
Measured: At 4-5 weeks follow-up
Late recurrence rate
To determine the recurrence rate at 24-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).
Measured: At 24-months follow-up
Late recurrence rate
To determine the recurrence rate at 60-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).
Measured: At 60-months follow-up
Mesh migration and mesh shrinkage
To evaluate the incidence of mesh migration and mesh shrinkage at 12-months follow-up via abdominal ultrasound (only in specialized investigational centers ).
Measured: At 12-months follow-up
Re-intervention
To determine the incidence of hernia surgery related re-interventions since the (robot-assisted) laparoscopic TEP or TAPP procedure.
Measured: At 5-years follow-up
Explantation rate
To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.
Measured: At 5-years follow-up
Return to daily activities
To determine the mean number of days when the patient returned to daily activities after the operation, assessed at 4-5 weeks follow-up.
Measured: At 4-5 weeks follow-up
Return to work
To determine the mean number of days when the patient returned to work after the operation, assessed at 4-5 weeks follow-up.
Measured: At 4-5 weeks follow-up
Pre-operative pain scoring
To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).
Measured: At baseline
Post-operative pain scoring
To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).
Measured: At discharge, an average of 1 day
Post-operative pain scoring
To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).
Measured: At 4-5 weeks follow-up
Post-operative pain scoring
To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).
Measured: At 12-months follow-up
Post-operative pain scoring
To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).
Measured: At 24-months follow-up
Post-operative pain scoring
To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).
Measured: At 60-months follow-up
Intake of analgesics
To register intake of analgesics.
Measured: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
Intake of analgesics
To register intake of analgesics.
Measured: At 4-5 weeks follow-up
Intake of analgesics
To register intake of analgesics.
Measured: At 12-months follow-up
Intake of analgesics
To register intake of analgesics.
Measured: At 24-months follow-up
Intake of analgesics
To register intake of analgesics.
Measured: At 60-months follow-up
QoL
To assess QoL by the EQ-5D questionnaire.
Measured: At baseline
QoL
To assess QoL by the EQ-5D questionnaire.
Measured: At 4-5 weeks follow-up
QoL
To assess QoL by the EQ-5D questionnaire.
Measured: At 12-months follow-up
QoL
To assess QoL by the EQ-5D questionnaire.
Measured: At 24-months follow-up
QoL
To assess QoL by the EQ-5D questionnaire.
Measured: At 60-months follow-up
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
Measured: At 4-5 weeks follow-up
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
Measured: At 12-months follow-up
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
Measured: At 24-months follow-up
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
Measured: At 60-months follow-up
Subjective groin symptoms
To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).
Measured: At 4-5 weeks follow-up
Subjective groin symptoms
To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).
Measured: At 12-months follow-up
Subjective groin symptoms
To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).
Measured: At 24-months follow-up
Subjective groin symptoms
To assess subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).
Measured: At 60-months follow-up
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 4-5 weeks follow-up
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 12-months follow-up
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 24-months follow-up
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 60-months follow-up
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 4-5 weeks follow-up
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 12-months follow-up
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 24-months follow-up
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Measured: At 60-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start30 Jun 2022
- Primary completion23 Sep 2025
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cousin Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306496
- Sponsor's protocol ID
- RAPID4D
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up
- ClinicalTrials.gov ID
- NCT05306496
- Acronym / sponsor ID
- RAPID4D
- Conditions
- Inguinal Hernia, Femoral Hernia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Cousin BiotechIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
- Patients with American Society of Anesthesiologists (ASA) grade I to III.
- Patient ≥ 18 years of age at study entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
Key exclusion criteria (12 listed)
- Patient has a recurrent inguinal or femoral hernia.
- Patient is treated using the Lichtenstein technique.
- Patients with ASA grade IV and V.
- Patient is allergic to the components of the 4DMESH®.
- Presence of an infected site.
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 |
|---|---|---|
| Pre-shaped 4DMESH®The 4DMESH® mesh is semi-resorbable parietal reinforcement implant made of 25% Polypropylene (non-resorbable) and 75% Poly-L-Lactic Acid (resorbable). 4DMESH® meshes are designed for the repair and reinforcement of inguinal and femoral hernias. 4DMesh is a CE-marked, class III medical device manufactured by Cousin Biotech. | Device | – |
Primary outcome
Hernia recurrence
Time frame: At 12-months follow-up
To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.
44 secondary outcomes
Technical success
Time frame: At index-procedure
Duration of surgery
Time frame: At index-procedure
Duration of hospital stay
Time frame: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
Peri- and post-operative complications related to 4DMESH®
Time frame: At 5-years follow-up
Early recurrences
Time frame: At 4-5 weeks follow-up
Late recurrence rate
Time frame: At 24-months follow-up
Late recurrence rate
Time frame: At 60-months follow-up
Mesh migration and mesh shrinkage
Time frame: At 12-months follow-up
Re-intervention
Time frame: At 5-years follow-up
Explantation rate
Time frame: At 5-years follow-up
Return to daily activities
Time frame: At 4-5 weeks follow-up
Return to work
Time frame: At 4-5 weeks follow-up
Pre-operative pain scoring
Time frame: At baseline
Post-operative pain scoring
Time frame: At discharge, an average of 1 day
Post-operative pain scoring
Time frame: At 4-5 weeks follow-up
Post-operative pain scoring
Time frame: At 12-months follow-up
Post-operative pain scoring
Time frame: At 24-months follow-up
Post-operative pain scoring
Time frame: At 60-months follow-up
Intake of analgesics
Time frame: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
Intake of analgesics
Time frame: At 4-5 weeks follow-up
Intake of analgesics
Time frame: At 12-months follow-up
Intake of analgesics
Time frame: At 24-months follow-up
Intake of analgesics
Time frame: At 60-months follow-up
QoL
Time frame: At baseline
QoL
Time frame: At 4-5 weeks follow-up
QoL
Time frame: At 12-months follow-up
QoL
Time frame: At 24-months follow-up
QoL
Time frame: At 60-months follow-up
EQ-5D change
Time frame: At 4-5 weeks follow-up
EQ-5D change
Time frame: At 12-months follow-up
EQ-5D change
Time frame: At 24-months follow-up
EQ-5D change
Time frame: At 60-months follow-up
Subjective groin symptoms
Time frame: At 4-5 weeks follow-up
Subjective groin symptoms
Time frame: At 12-months follow-up
Subjective groin symptoms
Time frame: At 24-months follow-up
Subjective groin symptoms
Time frame: At 60-months follow-up
Global groin symptoms
Time frame: At 4-5 weeks follow-up
Global groin symptoms
Time frame: At 12-months follow-up
Global groin symptoms
Time frame: At 24-months follow-up
Global groin symptoms
Time frame: At 60-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-shaped 4DMESH® in people with Inguinal Hernia and Femoral Hernia, run by Cousin Biotech at 9 sites in 3 countries.
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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Belgium, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hernia recurrence (time frame: At 12-months follow-up). 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 17 Apr 2026.