BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX for Complex ventral hernia|Ventral hernia

Inclusion criteria

• {"criterion_text":"- •\tParticipant is willing and able to give informed consent for participation in the trial"}
• {"criterion_text":"- •\tDefect width ≥ 10 cm"}
• {"criterion_text":"- •\tLoss of domain (LoD) ≥ 20% and cosmetic discomfort related to the ventral hernia, are negatively or positively influenced by BTA injections;"}
• {"criterion_text":"- •\tCompliance to follow-up"}
• {"criterion_text":"- •\tMale and female"}
• {"criterion_text":"- •\tWritten informed consent to preoperative BTA injection and/or surgery"}
• {"criterion_text":"- •\tAge ≥ 18 years old"}
• {"criterion_text":"- •\tPrimary ventral hernia"}
• {"criterion_text":"- •\tIncisional ventral hernia"}
• {"criterion_text":"- •\tRDR < 2"}

Exclusion criteria

• {"criterion_text":"- •\tMedical or psychiatric conditions that compromises the patient’s ability to give informed consent or comply with the study protocol"}
• {"criterion_text":"- •\tRefuse to give informed consent to preoperative BTA injection and/or surgery"}
• {"criterion_text":"- •\tPersonal reasons"}
• {"criterion_text":"- •\tAge < 18 years old"}
• {"criterion_text":"- •\tRDR ≥ 2"}
• {"criterion_text":"- •\tDefect width < 10 cm"}
• {"criterion_text":"- •\tLoD < 20%"}
• {"criterion_text":"- •\tPregnancy and breastfeeding"}
• {"criterion_text":"- •\tAllergy/Intolerance to BTA"}
• {"criterion_text":"- •\tNeuromuscular disorders and diseases"}

Primary endpoints

• {"endpoint_text":"- RDR is the ratio between the sum of the width of two recti to defect width. According to Love et al., with each increase of 0.5 in the RDR value, a linear decrease in the need for AMR of approximately 20% is achieved.","definition_or_measurement_approach":"Defined as the ratio between the sum of the width of the two recti muscles and the defect width; measured as described (per Love et al.) from imaging."}
• {"endpoint_text":"- CSI is calculated choosing a fixed point on a preoperative axial computed tomographic (CT) scan (aorta) and the medial leading edges of the rectus abdominus muscles. A CSI > 0.146 is a predictive score of myofascial release","definition_or_measurement_approach":"Calculated on preoperative axial CT using a fixed reference point (aorta) and medial leading edges of rectus abdominus; CSI > 0.146 predictive of myofascial release."}
• {"endpoint_text":"- Hernia width, LM length and width, and abdominal volume and diameters will also be measured. A hernia width > 10 cm is a predictive score of myofascial release","definition_or_measurement_approach":"Measured dimensions on imaging: hernia width, lateral muscle (LM) length and width, and abdominal cavity volume and diameters; hernia width >10 cm considered predictive."}

Secondary endpoints

• {"endpoint_text":"- •\tPBR is defined as % of peritoneal sac needed to achieve complete posterior fascial closure. It is the ratio between the area of peritoneal sac and the area of the posterior plane, obtained during the preperitoneal/pre-transversalis dissection","definition_or_measurement_approach":"PBR defined as percentage: (area of peritoneal sac / area of posterior plane) measured intraoperatively during preperitoneal/pre-transversalis dissection."}
• {"endpoint_text":"- •\tABR is defined as % of peritoneal sac needed to achieve complete anterior fascial closure. It is the ratio between the area of the peritoneal sac and the area of the anterior plane, obtained during the subcutaneous dissection","definition_or_measurement_approach":"ABR defined as percentage: (area of peritoneal sac / area of anterior plane) measured intraoperatively during subcutaneous dissection."}
• {"endpoint_text":"- •\tWhen a PCS with TAR is performed, different percentage of ABR e PBR may correlate with efficacy outcomes of BTA injection:","definition_or_measurement_approach":"Exploratory correlation of ABR and PBR percentages with efficacy outcomes when PCS with TAR is performed; measurement methods as defined for ABR/PBR."}

Italy

Earliest CTIS Part Ii Submission Date

23-10-2025

Latest Decision Or Authorization Date

17-02-2026

Processing Time Days

117

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Azienda Socio Sanitaria Territoriale Ovest Milanese

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"IPSEN S.p.A.","duties_or_roles":"Source of monetary support (listed in sourceOfMonetarySupport).","organisation_type":""}
• {"country":"United Kingdom","full_name":"IPSEN LTD","duties_or_roles":"Listed as product 'nameOrg' in product dictionary associated with the investigational product (IMP).","organisation_type":""}