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New treatment option for Incisional Hernia
Official title Surgery with Botulinum Toxin a for Incisional Hernia
ClinicalTrials.gov ID: NCT06499324
What this study is testing
What is BTA group?
BTA group is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for incisional hernia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After laparotomy, treating large incisional hernias (width \>= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Patients between 18 and 79 years;
- BMI \< 35 kg/m²;
- Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width \>= 10 cm, on the abdominopelvic CT without injection of contrast...
- IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) \< 25%, on the abdominal CT without...
- Written informed consent;
You likely can't join if
- Other types of IH (lateral, groin, para-stomal, portsite);
- VHWG grades 3 or 4 for the risk of surgical site infection;
- Ongoing skin infection or inflammation at the IH site or at the BTA injection site;
- Planned IH repair with slowly absorbable mesh;
- IH with loss of domain (volumetric ratio \> 25%);
- Emergency IH surgery;
See the full eligibility criteria
- Patients between 18 and 79 years;
- BMI \< 35 kg/m²;
- Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width \>= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3);
- IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) \< 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion;
- Written informed consent;
- Scheduled surgery for an open IH repair;
- For female of childbearing potential: using highly effective contraception.
- Other types of IH (lateral, groin, para-stomal, portsite);
- VHWG grades 3 or 4 for the risk of surgical site infection;
- Ongoing skin infection or inflammation at the IH site or at the BTA injection site;
- Planned IH repair with slowly absorbable mesh;
- IH with loss of domain (volumetric ratio \> 25%);
- Emergency IH surgery;
- ASA score \> 3;
- Pregnancy or breastfeeding;
- Ongoing treatment with aminoglycosides;
- Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant;
- Active tobacco use (or cessation inferior to 3 months);
- Use of another investigational product within 6 months or 5 half-lives (whichever is longer), or currently participating in a prospective study with an investigational product, whether it concerns an experimental drug...
- Patient not covered by social insurance;
- Patient under legal guardianship;
- Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose);
- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome, peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy), facial nerve disorders...
- Patient with ongoing treatment with medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g. tubocurarine-type muscle relaxants that weaken the muscles;
- Patient with severe and uncontrolled cardiovascular diseases;
- Patient has received BTA within 12 weeks;
- Patients with a history of seizures.
The study team makes the final eligibility decision.
Where it's taking place
- Colombes, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombes, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.