Indigotindisulfonate de sodium injectable, USP comme aide à la détermination de la perméabilité urétérale
Une étude ouverte, randomisée et multicentrique pour évaluer l'innocuité, l'efficacité et la satisfaction des médecins de deux doses différentes de Bludigo™ (Indigotindisulfonate de sodium injectable, USP) 0,8 % lorsqu'il est utilisé comme aide à la détermination de la perméabilité urétérale
This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo when used as an aid in the determination of ureteral patency.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. Screening will occur within 30 days before study drug administration (Day of Surgery). After signing the informed consent, review of inclusion and exclusion criteria will be performed, the collection of concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
New York
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Albany, New York, États-Unis, 12008
- Albany Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subjects between ≥ 18 and ≤ 85 years old
- Subjects who signed a written IRB approved, informed consent form
- Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure
Exclusion Criteria:
- Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min (calculated using the MDRD formula and standardized by using individual's body surface area) or need for dialysis in the near future, or having only 1 kidney
- Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes
- Known history of drug or alcohol abuse within 6 months prior to the time of screening visit
- Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases)
- Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures
- Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Subjects with life expectancy < 6 months
- Requirement for concomitant treatment that could bias primary evaluation.
- Subjects who are pregnant or breast-feeding
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Saline
116 subjects treated with 5 ml of saline then crossover to treatment arm |
Placebo |
|
Expérimental: High Dose
58 subjects randomly treated with 5 mL of drug |
Placebo Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
Autres noms:
|
|
Expérimental: Low Dose
58 subjects randomly treated with 2.5 mL of drug |
Placebo Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .
Délai: 10 minutes post study drug administration
|
Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows:
Paired sample difference (Bludigo™-Saline) in conspicuity score (PSDCS). PSDCS will be calculated for each ureter (left or right) for each subject from each reviewer. |
10 minutes post study drug administration
|
|
Responders to Bludigo
Délai: 10 Minutes post study drug administration
|
Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows:
A subject is considered a responder to Bludigo™ if there is >=1 point improvement in the conspicuity score following the Bludigo™- treatment vs the saline treatment and the conspicuity score for the Bludigo™ treatment must be (3, 4, or 5). The responder criteria will be assessed separately for each ureter (left or right) from each reviewer. |
10 Minutes post study drug administration
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of adverse events and serious adverse events.
Délai: 30 days post study drug administration
|
Percentage of patients in each treatment group who experience an adverse event post treatment |
30 days post study drug administration
|
|
Changes in clinical safety laboratory values
Délai: 30 days post study drug administration
|
Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment |
30 days post study drug administration
|
|
Changes in vital signs post treatment
Délai: 30 days post study drug administration
|
Proportion of subjects with clinically important changes in vital signs after treatment |
30 days post study drug administration
|
|
Changes in ECG post treatment
Délai: 30 days post study drug administration
|
Proportion of subjects with clinically important changes in ECGs after treatment |
30 days post study drug administration
|
|
Changes in blood pressure by dose group and BMI (kg/m^2)
Délai: 30 days post study drug administration
|
Comparison of post treatment changes in blood pressure by dose group and BMI (kg/m^2) |
30 days post study drug administration
|
|
Changes in heart rate by dose group and BMI (kg/m^2)
Délai: 30 days post study drug administration
|
Comparison of post treatment changes in heart rate by dose group and BMI (kg/m^2) |
30 days post study drug administration
|
|
Changes in pulse oximetry by dose group and BMI (kg/m^2)
Délai: 30 days post study drug administration
|
Comparison of post treatment changes in pulse oximetry by dose group and BMI (kg/m^2) |
30 days post study drug administration
|
|
Physician Satisfaction
Délai: 10 Minutes post study drug administration
|
To determine physicians' overall satisfaction with the Bludigo™ treatment by assessing the proportion of surgeons who agree using the 5-point Physician Satisfaction Agreement Scale (PSAS) with the statement: "Compared to the saline treatment, my ability to assess ureter patency was improved after the addition of Bludigo™."
|
10 Minutes post study drug administration
|
|
Time to visualization
Délai: 10 minutes post study drug administration
|
To describe the time to visualization (TTV) of blue color in the ureteral jets flow following Bludigo™ treatment |
10 minutes post study drug administration
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Michelle Boytim, Ph.D., Provepharm SAS
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PVP-22IC04
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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