Status:
COMPLETED
Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.
Lead Sponsor:
Quanta Medical
Collaborating Sponsors:
Cousin Biotech
Conditions:
Inguinal Hernia
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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. Based on ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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;
- 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
Exclusion
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT04033055
Start Date
October 31 2019
End Date
March 12 2024
Last Update
March 20 2025
Active Locations (1)
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1
Amiens Picardie university hospital
Amiens, France, 80054