Inguinal HerniaHENRINCT04033055
Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.
A study testing Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL and Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°° in people with Inguinal Hernia, run by Quanta Medical at 1 site in France.
Trial summary
CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL and Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2019to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease-related criteria:
- Uncomplicated and non-recurrent unilateral symptomatic inguinal hernia with a surgical indication
- Bilateral inguinal hernia symptomatic on one side and requiring surgery on the symptomatic side
- Symptomatic, normal unilateral inguino-scrotal hernia (located above the middle of the inner thigh), uncomplicated and non-recurrent, with an indication for surgery by local inguinal approach without testicular redonation.
- Open surgery with Lichtenstein's technique;
- Programmed outpatient surgery;
Show all 32Show fewer
- Surgery performed under general anesthesia.
- Population-related criteria:
- Male subjects over 18 years old;
- Subjects who have given their free informed signed consent to participate in the study;
- Subjects who are affiliated to a social security system or have rights from a social security system.
- Non inclusion Criteria:
- Disease-related criteria:
- Strangulated inguinal or inguino-scrotal hernia;
- Bilateral inguinal hernia symptomatic on both sides and requiring surgery on both sides
- Chronic pain state (> 3 months) and/or long term analgesics intake susceptible to hide or interfere with pain assessment;
- Hepatic or renal failure and any other pathology that could notably extend half-life of anaesthetics and analgesics products
- Signs of infection at the surgical site;
- Severe cardiopulmonary, hepatic or renal diseases
- Active ongoing malignant disease;
- Product or device-related criteria:
- Known allergy or hypersensitivity to any of the constituents of the CycloMesh (Polyethylene terephthalate + Cyclodextrin) and/or subjects allergic to ropivacaine;
- Allergy to any drugs of the anesthesia protocol;
- Population-related criteria:
- Drug or alcohol abuse (addiction: i.e. chronic alcoholism or active drug addiction)
- Daily intake of level I analgesics (Paracetamol, Aspirin, Ibuprofen...etc.), for > 6 weeks.
- Use of corticosteroids within 24 hours prior to the surgery.
- Chronic use of antidepressants, anxiolytics, neuroleptics since 1 month or more,
- In case of occasional use, taking antidepressants, anxiolytics, neuroleptics in the 72 h prior to the intervention
- Unavailability during the study
- Participation in a clinical trial within 3 months prior to the initial visit.
- Psychiatric pathology or depressive disorder
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study of Antalgic Efficacy of the CycloMesh™ Implant Soaked in Ropivacaine Hydrochloride 10 Mg/mL in the Treatment of Uncomplicated Inguinal Hernia. Randomized Comparative Study Versus CycloMesh™ Soaked in Physiological Saline Solution NaCl 9°/°°
CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery.
The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.
- Conditions
- Inguinal Hernia
- Being tested
- Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL, Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mLProcedure or surgery
The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique).
CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed.
Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°Procedure or surgery
The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique).
CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed.
| Study group | Role | What they receive |
|---|---|---|
| CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL | Experimental | The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique).
CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed. Receives: Procedure: Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL |
| CycloMesh™ soaked in saline solution 9°/°° | Active comparator | The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique).
CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed. Receives: Procedure: Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°° |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations.
Pain assessment will be performed 6 hours after implant placement and during cough effort.
Measured: 6 hours post-surgery
Secondary outcomes (18)
Pain intensity back to home (Day 0) and Day 1 to 3 will be assessed using a Visual Analogic Scale (VAS)
Pain intensity will be reported by the patient on a log book using a Visual Analogic Scale . The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate
Measured: Back to home (Day 0) at 8pm and 10 pm, Twice a day (8 am and 8 pm) at Day 1, Day 2 and Day 3
Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a Visual Analogic Scale (VAS)
Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a visual analogic scale and during a telephone interview performed by an investigator's collaborator.
The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate.It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations.
Measured: Day 1 and Day 7 post-surgery
Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS)
Pain intensity at 1 month post-surgery will be assessed, using a visual analogic scale, during a visit to the surgeon and in 3 different situations: at rest, walking and during cough effort.The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate.It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations.
Measured: 1 month post-surgery
Hospitalization lenght (in hours)
In case of delayed discharge (the day after the surgery or prolongation of hospitalization), the reasons of prolonged hospital treatment will be collected
Measured: 1 week post-surgery
Duration of surgical time from the first incision until wound closure (in minutes)
Duration of surgical time from the first incision until wound closure will be calculated in minutes
Measured: At the moment of wound closure
Evolution between inclusion and 24 months post-surgery with regard to quality of life
Quality of life will be assessed using the 36-item Short Form Health Survey (SF-36) score at inclusion and 1 month post-surgery: SF-36 is a standardized and validated questionnaire assessing quality of life. The SF-36 provides two scores: a mental and social quality of life score and a physical quality of life score
Measured: Inclusion and 1 month post-surgery 12 and 24 months post-surgery
The amount of consumed analgesic will be assessed using post-operative data and data reported by the patient on a log book
The amount of consumed analgesic will be measured by calculating the number of patients who have consumed analgesic during the 7 post-operative and antalgic intake (in mg) during the 7 post-operative
Measured: 7 days post-surgery period
Time to return to work or activity post-surgery
The Time to return to work or activity following surgery will be evaluated in terms of the number of days between hospitalisation and resumption of activity
Measured: Day 1, Day 7 and 1 month post-surgery
The rate of early recurrence (at 1 month postoperative) and at long term (12 and 24 months) will be assessed
Rates of early reccurence during the study (up to one month after surgery). The long-term recurrence rate will also be assessed at 12 and 24 months post-operatively. Recurrence is defined as the reappearance of the hernia on the same side as the one initially operated on, whether the recurrence required surgical intervention.
Measured: All study period (24-months)
Number of patients presenting at least one adverse event (AE)
The safety and tolerability end points will be will be as follows: number of patients presenting at least one adverse event (AE)
Measured: All study period (24-months)
Number of patients presenting at least one AE related to the the device implantation
The safety and tolerability end points will be will be as follows: number of patients presenting at least one AE related to the the device implantation
Measured: All study period (24-months)
Number of patients presenting at least one serious adverse event (SAE)
The safety and tolerability end points will be will be as follows: number of patients presenting at least one serious adverse event (SAE)
Measured: All study period (24-months)
Total number of AE related to the device implantation, classified by type and organ
The safety and tolerability end points will be will be as follows: total number of AE related to the device implantation, classified by type and organ
Measured: All study period (24-months)
Satisfaction of the surgeon and unit staff regarding the use of CycloMesh will be evaluated using a satisfaction questionnaire
Surgeon and unit staff will have to answer to a questionnaire concerning the packaging of CycloMesh, the technical characteristics of the implant (flexibility, porosity, etc.), its size, time imbibition of CycloMesh, etc.
Measured: Day 0
Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations.
Pain assessment will be performed 6 hours after implant placement at rest and walking
Measured: 6 hours post-surgery
The rate of patient with chronic pain at 12 and 24 months
Chronic pain is defined as pain that lasts for at least 6 months after surgery
Measured: 12-months after surgery and 24-months after surgery
The rate of implant migration at 12 and 24 months
Migration is defined as the movement of the entire implant into an organ.
Measured: 12-months after surgery and 24-months after surgery
The rate of foreign body sensation at 12 and 24 months postoperative
Foreign body sensation is assessed by answering yes or no to the question: do you feel a foreign body in the groin
Measured: 12-months after surgery and 24-months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start31 Oct 2019
- Primary completion16 Mar 2022
- Study completion12 Mar 2024
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033055
- Sponsor's protocol ID
- 2891
- Acronym
- HENRI
- Status last verified
- Mar 2024
- First submitted
- 15 Jul 2019
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of Antalgic Efficacy of the CycloMesh™ Implant Soaked in Ropivacaine Hydrochloride 10 Mg/mL in the Treatment of Uncomplicated Inguinal Hernia. Randomized Comparative Study Versus CycloMesh™ Soaked in Physiological Saline Solution NaCl 9°/°°
- ClinicalTrials.gov ID
- NCT04033055
- Acronym / sponsor ID
- HENRI / 2891
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 25 Jul 2019 (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.
CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery.
The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL | Experimental | Procedure: Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mLThe surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed. |
| CycloMesh™ soaked in saline solution 9°/°° | Active comparator | Procedure: Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Uncomplicated and non-recurrent unilateral symptomatic inguinal hernia with a surgical indication
- Bilateral inguinal hernia symptomatic on one side and requiring surgery on the symptomatic side
- Symptomatic, normal unilateral inguino-scrotal hernia (located above the middle of the inner thigh), uncomplicated and non-recurrent, with an indication for surgery by local inguinal approach without testicular redonation.
- Open surgery with Lichtenstein's technique;
- Programmed outpatient surgery;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mLThe surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed. | Procedure or surgery | CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL |
| Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed. | Procedure or surgery | CycloMesh™ soaked in saline solution 9°/°° |
Primary outcome
Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
Time frame: 6 hours post-surgery
The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations. Pain assessment will be performed 6 hours after implant placement and during cough effort.
18 secondary outcomes
Pain intensity back to home (Day 0) and Day 1 to 3 will be assessed using a Visual Analogic Scale (VAS)
Time frame: Back to home (Day 0) at 8pm and 10 pm, Twice a day (8 am and 8 pm) at Day 1, Day 2 and Day 3
Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a Visual Analogic Scale (VAS)
Time frame: Day 1 and Day 7 post-surgery
Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS)
Time frame: 1 month post-surgery
Hospitalization lenght (in hours)
Time frame: 1 week post-surgery
Duration of surgical time from the first incision until wound closure (in minutes)
Time frame: At the moment of wound closure
Evolution between inclusion and 24 months post-surgery with regard to quality of life
Time frame: Inclusion and 1 month post-surgery 12 and 24 months post-surgery
The amount of consumed analgesic will be assessed using post-operative data and data reported by the patient on a log book
Time frame: 7 days post-surgery period
Time to return to work or activity post-surgery
Time frame: Day 1, Day 7 and 1 month post-surgery
The rate of early recurrence (at 1 month postoperative) and at long term (12 and 24 months) will be assessed
Time frame: All study period (24-months)
Number of patients presenting at least one adverse event (AE)
Time frame: All study period (24-months)
Number of patients presenting at least one AE related to the the device implantation
Time frame: All study period (24-months)
Number of patients presenting at least one serious adverse event (SAE)
Time frame: All study period (24-months)
Total number of AE related to the device implantation, classified by type and organ
Time frame: All study period (24-months)
Satisfaction of the surgeon and unit staff regarding the use of CycloMesh will be evaluated using a satisfaction questionnaire
Time frame: Day 0
Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
Time frame: 6 hours post-surgery
The rate of patient with chronic pain at 12 and 24 months
Time frame: 12-months after surgery and 24-months after surgery
The rate of implant migration at 12 and 24 months
Time frame: 12-months after surgery and 24-months after surgery
The rate of foreign body sensation at 12 and 24 months postoperative
Time frame: 12-months after surgery and 24-months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL and Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°° in people with Inguinal Hernia, run by Quanta Medical at 1 site 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 32 inclusion and 0 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS). (time frame: 6 hours post-surgery). 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 20 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.