Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462066
Status:
COMPLETED
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Effectiveness Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
Sponsor:
GEM SRL
Organization:
GEM SRL
Study Overview
Official Title:
Effectiveness Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue NBCA n Butyl 2 Cyanoacrylate OCA 2-Octyl-Cyanoacrylate Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery Inguinal and Ventral Hernia Repair by Sublay Underlay and IPOM Mesh Fixation
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGluTHeMFix
Brief Summary:
This pre-market prospective randomized non-inferiority clinical study was designed to evaluate the safety and performanceeffectiveness of Glutack-Glubran Tiss 2 system compared to Glutack-Glubran used for mesh fixation in laparoscopic and robotic hernia surgery to obtain the indication and upgrade the medical device Glubran Tiss 2 to class IIbCyanoacrylate is the generic name of a group of fast-acting adhesives such as ethyl-2-cyanoacrylate n-butyl cyanoacrylate 2-octy1 cyanoacrylate sold under various trade names and blend Cyanoacrylate is a liquid acrylate monomer that polymerizes exothermically in the presence of water especially with hydroxide ions joining the bonded surfaces in 4-5 s and reaching the final stage in 60-90 s It bonds body tissue excellently and shows bacteriostatic effects The film of glue is eliminated by hydrolytic breakdown a process whose duration varies according to tissue type and quantity
In contrast to most cyanoacrylate glues used only for external applications as skin wound closure Glubran 2 is a modified n-butyl-cyanoacrylate Glubran 2 - N-Butyl 2 Cyanoaciylate NBCA Methacryloxysulfolane MS class III medical device CE-certified for both external and internal use
Glubran 2 effectiveness in repairing hernias with less post-operative pain less complications less hernia recurrences and a greater cost-effectiveness is largely documented Other cyanoacrylate-based glues are authorized to fix hernia meshes ie Histoacryl pure NBCA classified as class IIb medical device Liquibond FIX8 pure NBCA classified as class III medical device and Ifabond n-hexyl-cyanoacrylate classified as class III medical device Others are authorized to be used for specific internal indication like Omnex 2-Octyl-CyanoAcrylate OCA Butyl-Lactoyl-Cyanoacrylate which is indicated for use in vascular reconstructions Sometimes abroad also some cyanoacrylate-based glues are applied for internal uses even if not authorized
The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran Tiss 2 NBCA OCA classified as class IIa surgical medical device CE-marked under the European Union EU Directive 9342 EEC being already authorized for use as atraumatic fixation system Glubran 2 Both medical devices have previously demonstrated to be well-tolerated and safe
Glubran 2 and Glubran Tiss 2 were to be applied by Glutack a CE-marked medical device system for glue application in the surgical field Glutack is the related Glubran 2 Glubran Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran glues
Glubran Tiss 2 fulfils the requirements of EU Medical Device Regulation MDR 2017745 confirmation letter received by the relative Notified Body The composition of Glubran Tiss 2 is obtained by mixing two different monomers of cyanoacrylate NBCA OCA this gives the product a better elasticity while maintaining high levels of tensile strength In fact international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength 3427 N low elasticity while OCA has a lower resistance 1127 N but has good elastic properties Glubran Tiss 2 glue has a tensile strength of 2734 N and thanks to the presence of OCA also excellent elasticity Among its characteristics this formulation has haemostatic sealing bacteriostatic and adhesive properties Polymerization begins 1-2 seconds after application and completes within 60 seconds The polymerization reaction generates a temperature of approximately 45C which is lower than that of pure cyanoacrylates
Glubran Tiss 2 indicated also for use in paediatrics is a sterile ready for use blended cyanacrylate adhesive to be used on the skin and mucosal tissues which is approved as class IIa medical device effective even in patients anticoagulated and with congenital coagulopathies
In contrast to most cyanoacrylate glues used only for external applications as skin wound closure Glubran 2 is a modified n-butyl-cyanoacrylate Glubran 2 - N-Butyl 2 Cyanoaciylate NBCA Methacryloxysulfolane MS class III medical device CE-certified for both external and internal use
Glubran 2 effectiveness in repairing hernias with less post-operative pain less complications less hernia recurrences and a greater cost-effectiveness is largely documented Other cyanoacrylate-based glues are authorized to fix hernia meshes ie Histoacryl pure NBCA classified as class IIb medical device Liquibond FIX8 pure NBCA classified as class III medical device and Ifabond n-hexyl-cyanoacrylate classified as class III medical device Others are authorized to be used for specific internal indication like Omnex 2-Octyl-CyanoAcrylate OCA Butyl-Lactoyl-Cyanoacrylate which is indicated for use in vascular reconstructions Sometimes abroad also some cyanoacrylate-based glues are applied for internal uses even if not authorized
The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran Tiss 2 NBCA OCA classified as class IIa surgical medical device CE-marked under the European Union EU Directive 9342 EEC being already authorized for use as atraumatic fixation system Glubran 2 Both medical devices have previously demonstrated to be well-tolerated and safe
Glubran 2 and Glubran Tiss 2 were to be applied by Glutack a CE-marked medical device system for glue application in the surgical field Glutack is the related Glubran 2 Glubran Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran glues
Glubran Tiss 2 fulfils the requirements of EU Medical Device Regulation MDR 2017745 confirmation letter received by the relative Notified Body The composition of Glubran Tiss 2 is obtained by mixing two different monomers of cyanoacrylate NBCA OCA this gives the product a better elasticity while maintaining high levels of tensile strength In fact international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength 3427 N low elasticity while OCA has a lower resistance 1127 N but has good elastic properties Glubran Tiss 2 glue has a tensile strength of 2734 N and thanks to the presence of OCA also excellent elasticity Among its characteristics this formulation has haemostatic sealing bacteriostatic and adhesive properties Polymerization begins 1-2 seconds after application and completes within 60 seconds The polymerization reaction generates a temperature of approximately 45C which is lower than that of pure cyanoacrylates
Glubran Tiss 2 indicated also for use in paediatrics is a sterile ready for use blended cyanacrylate adhesive to be used on the skin and mucosal tissues which is approved as class IIa medical device effective even in patients anticoagulated and with congenital coagulopathies
Detailed Description:
This was a pre-market prospective randomized non-inferiority clinical study aimed at evaluating the safety and performanceeffectiveness of Glutack-Glubran Tiss 2 system compared to Glutack-Glubran 2 applied for mesh fastening in laparoscopic and robotic hernia surgery to get the indication and upgrade Glubran Tiss 2 to class IIb The study was conducted in seven centres in Italy and was to enroll 100 patients Patients were to be followed for 6 months The global duration of the trial was approximately 32 months
According to the CIP 6 Visits were planned over the perioperativepost operative period for each patient after 24 hours7 14 90 and 180 days
At Visit 1 V1 day 0 Baseline visit patients were requested to sign the written informed consent before any procedure was performed Patients were screened for eligibility for the study ascertaining that all inclusion criteria and no exclusion criteria were met At V1 the Investigator recorded demographic and medical history basal clinical assessment data and performed full physical examination and evaluation of clinical signssymptoms
Patients were randomly assigned 11 allocation ratio to one of the two treatment groups Glutack-Glubran system Group 1 or Glutack-Glubran Tiss 2 Group 2 The application of Glutack-Glubran system or Glutack-Glubran Tiss 2 was performed by the investigator after a previous appropriate training on how to assembleuse each device
Technical success of glue fastening was evaluated intra-operatively the investigator registered whether mesh fixation system achieved technical success or not Technical success was to be defined as successful hernia repair as intended but actually defined in the present analysis as a surgical procedure with no complications within the first 24 hours after surgery and a surgeons rating for Efficacy and Control greater than or equal to 4At specific intervals at V2 24 hours V3 7 days V4 14 days V5 90 days and V6 180 days patients were requested to return to the centre for the clinical assessments of safety quality of life and effectiveness As regards effectiveness at each Visit the area of the mesh implant was evaluated for recurrence through a specific abdominal clinical examination In case of any suspicion of recurrence an ultrasound or MRI was to be performed according to hospital practice to distinguish true hernia recurrences from bulging At V6 cost effectiveness was also to be evaluatedThe primary objective of the study was to assess the effectiveness of Glutack-Glubran Tiss 2 mesh fastening in comparison with mesh fixation by Glutack-Glubran 2 evaluated in terms of hernia recurrence rate after surgery and technical success of glue fastening evaluated intra-operatively
The secondary objectives were aimed at investigating the following
1 Safety in terms of side effects
2 Cost effectiveness in terms of direct costs of intervention operating and hospitalization times times of return to normal activity
3 The adequacy of Glutack medical device for the application of surgical glue for fixing the prosthesis mesh in terms of ease of use and satisfaction of the surgeon
This study enrolled 107 adult patients submitted to surgical treatment for laparoceles incisional hernia or monolateral or bilateral inguinal hernia
631 Inclusion Criteria
Patients could be enrolled in the investigation if they met all the following inclusion criteria
1 No significant cardiopulmonary hepatic or renal impairment and no contraindications for surgery
2 Clinical diagnosis of
1 bilateral inguinal hernia eligible for minimally invasive repair TAPP-TEP VLSROB
2 recurrent monoliteral inguinal hernia TAPP-TEP VLSROB
3 large inguinoscrotal hernias TAPP-TEP ROB
4 primary ventral hernia with defects size 7cm IPOM-TARUP-COSTA-THT-MILOS-eMILOS VLSROB
5 primary abdominal border hernia idem VLSROB
6 post-incisional hernia with defect size 7cm idem VLS
7 post-incisional hernia and complex abdomen RIVES-RIVESTAR ROB
8 Swiss-cheese defects multiple small defects if treatable with only one mesh if the total width of the defect is 5cm will be repaired by IPOM VLSM if it is 5cm will be repaired by RIVES-RIVESTAR ROB
3 Age 18 years male and Female
4 Obese patient BMI35
5 Patients with ASA grade from I to III
6 Patients must sign and date the informed consent form prior to treatment 632 Exclusion Criteria
Patients could not be enrolled in the investigation if they met any of the following exclusion criteria
1 Incarcerated hernia
2 Allergy to multiple classes of drugs recent allergic disease or use of drugs that are known harmful to vital organs during the 4 weeks before surgery
3 Patients with ASA IV or V
4 Participations in other clinical studies in the 3 months before surgery
5 Atopic allergy history
6 Mental illness history
7 Diseases that may significantly increase Intra-Abdominal Pressure IAP and cannot be effectively controlled such as severe ascites severe asthma caused by bronchitis pulmonary emphysema or urine retention caused by significant Benign Prostatic Hyperplasia BPH
8 Infection located at the surgical site or bacteraemia
9 Patients with collagenopathies
10 Relevant other concurrent diseases
11 Patient with neurological disorders andor mood disorders
12 Hyperemotional patients
13 Pregnant women
According to the CIP 6 Visits were planned over the perioperativepost operative period for each patient after 24 hours7 14 90 and 180 days
At Visit 1 V1 day 0 Baseline visit patients were requested to sign the written informed consent before any procedure was performed Patients were screened for eligibility for the study ascertaining that all inclusion criteria and no exclusion criteria were met At V1 the Investigator recorded demographic and medical history basal clinical assessment data and performed full physical examination and evaluation of clinical signssymptoms
Patients were randomly assigned 11 allocation ratio to one of the two treatment groups Glutack-Glubran system Group 1 or Glutack-Glubran Tiss 2 Group 2 The application of Glutack-Glubran system or Glutack-Glubran Tiss 2 was performed by the investigator after a previous appropriate training on how to assembleuse each device
Technical success of glue fastening was evaluated intra-operatively the investigator registered whether mesh fixation system achieved technical success or not Technical success was to be defined as successful hernia repair as intended but actually defined in the present analysis as a surgical procedure with no complications within the first 24 hours after surgery and a surgeons rating for Efficacy and Control greater than or equal to 4At specific intervals at V2 24 hours V3 7 days V4 14 days V5 90 days and V6 180 days patients were requested to return to the centre for the clinical assessments of safety quality of life and effectiveness As regards effectiveness at each Visit the area of the mesh implant was evaluated for recurrence through a specific abdominal clinical examination In case of any suspicion of recurrence an ultrasound or MRI was to be performed according to hospital practice to distinguish true hernia recurrences from bulging At V6 cost effectiveness was also to be evaluatedThe primary objective of the study was to assess the effectiveness of Glutack-Glubran Tiss 2 mesh fastening in comparison with mesh fixation by Glutack-Glubran 2 evaluated in terms of hernia recurrence rate after surgery and technical success of glue fastening evaluated intra-operatively
The secondary objectives were aimed at investigating the following
1 Safety in terms of side effects
2 Cost effectiveness in terms of direct costs of intervention operating and hospitalization times times of return to normal activity
3 The adequacy of Glutack medical device for the application of surgical glue for fixing the prosthesis mesh in terms of ease of use and satisfaction of the surgeon
This study enrolled 107 adult patients submitted to surgical treatment for laparoceles incisional hernia or monolateral or bilateral inguinal hernia
631 Inclusion Criteria
Patients could be enrolled in the investigation if they met all the following inclusion criteria
1 No significant cardiopulmonary hepatic or renal impairment and no contraindications for surgery
2 Clinical diagnosis of
1 bilateral inguinal hernia eligible for minimally invasive repair TAPP-TEP VLSROB
2 recurrent monoliteral inguinal hernia TAPP-TEP VLSROB
3 large inguinoscrotal hernias TAPP-TEP ROB
4 primary ventral hernia with defects size 7cm IPOM-TARUP-COSTA-THT-MILOS-eMILOS VLSROB
5 primary abdominal border hernia idem VLSROB
6 post-incisional hernia with defect size 7cm idem VLS
7 post-incisional hernia and complex abdomen RIVES-RIVESTAR ROB
8 Swiss-cheese defects multiple small defects if treatable with only one mesh if the total width of the defect is 5cm will be repaired by IPOM VLSM if it is 5cm will be repaired by RIVES-RIVESTAR ROB
3 Age 18 years male and Female
4 Obese patient BMI35
5 Patients with ASA grade from I to III
6 Patients must sign and date the informed consent form prior to treatment 632 Exclusion Criteria
Patients could not be enrolled in the investigation if they met any of the following exclusion criteria
1 Incarcerated hernia
2 Allergy to multiple classes of drugs recent allergic disease or use of drugs that are known harmful to vital organs during the 4 weeks before surgery
3 Patients with ASA IV or V
4 Participations in other clinical studies in the 3 months before surgery
5 Atopic allergy history
6 Mental illness history
7 Diseases that may significantly increase Intra-Abdominal Pressure IAP and cannot be effectively controlled such as severe ascites severe asthma caused by bronchitis pulmonary emphysema or urine retention caused by significant Benign Prostatic Hyperplasia BPH
8 Infection located at the surgical site or bacteraemia
9 Patients with collagenopathies
10 Relevant other concurrent diseases
11 Patient with neurological disorders andor mood disorders
12 Hyperemotional patients
13 Pregnant women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None