Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CoSeal Surgical Group · 1 trial · 3 indications
Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Post-operative bleeding through surgical site drainage output.
Skin to bypass time as an indicator of adhesion burden.
| Arm | Type | Description |
|---|---|---|
| No CoSeal Surgical Spray | NO_INTERVENTION | A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure. |
| CoSeal Spray Group | EXPERIMENTAL | CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. |
| Name | Type | Description |
|---|---|---|
| CoSeal Surgical Spray Group | DEVICE | A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows: * Patients weighing \< 3kg will receive 1ml of CoSeal * Patients weighing 3-10kg will receive 1-2ml of CoSeal * Patients weighing \>10kg will receive 2-4ml of CoSeal |
Inclusion Criteria: * Have an acceptable surrogate capable of giving consent on the subject's behalf. * Pediatric patients ages 0 - 17 * Have a cardiac disease which requires staged cardiac surgery and resternotomy * Non-emergent state or emergent state with sufficient time to educate and consent ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Longeveron Inc. Class A | LGVN | 1 | PHASE2 | Lomecel-B medicinal signaling cells |
| Abbott Laboratories | ABT | 3 | N/A | Undisclosed |
| Edwards Lifesciences Corporation | EW | 3 | - | Undisclosed |
| Cardio Diagnostics Holdings Inc. | CDIO | 1 | N/A | Undisclosed |
CoSeal Surgical Group is an investigational product being studied for use in congenital heart defect surgery. A Phase 2 clinical trial evaluated its effects on bleeding and adhesions in pediatric heart surgery, with the goal of reducing surgery-induced tissue adhesions and hemorrhage in patients undergoing procedures for congenital heart defects.
CoSeal Surgical Group is being developed by Baxter International Inc., a company publicly traded under the ticker symbol BAX. The product is currently in clinical development and has not been approved for commercial use.
CoSeal Surgical Group is in Phase 2 clinical development. It is an investigational product, meaning it has not yet received regulatory approval and is still being studied for safety and efficacy in patients with congenital heart defects.
CoSeal Surgical Group has one completed Phase 2 clinical trial, identified as NCT01330433, titled 'Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery.' The trial enrolled 35 participants in the United States and studied the product's effects on bleeding and adhesions in pediatric heart surgery.
CoSeal Surgical Group is not FDA approved. It is an investigational product currently in Phase 2 clinical development. The completed trial NCT01330433 studied its effects on bleeding and adhesions in pediatric heart surgery, but the product has not yet received regulatory approval for any use.