요관 개방성 측정에 도움이 되는 인디고틴디설포네이트 나트륨 주사, USP
요관 개방성 결정을 위한 보조제로 사용되는 Bludigo™(인디고틴디설폰산 나트륨 주사제, USP) 0.8%의 두 가지 용량에 대한 안전성, 유효성 및 의사 만족도를 평가하기 위한 공개 라벨, 무작위, 다기관 연구
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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New York
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Albany, New York, 미국, 12008
- Albany Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Saline
116 subjects treated with 5 ml of saline then crossover to treatment arm |
Placebo |
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실험적: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of adverse events and serious adverse events.
기간: 30 days post study drug administration
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Percentage of patients in each treatment group who experience an adverse event post treatment |
30 days post study drug administration
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Changes in clinical safety laboratory values
기간: 30 days post study drug administration
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Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment |
30 days post study drug administration
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Changes in vital signs post treatment
기간: 30 days post study drug administration
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Proportion of subjects with clinically important changes in vital signs after treatment |
30 days post study drug administration
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Changes in ECG post treatment
기간: 30 days post study drug administration
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Proportion of subjects with clinically important changes in ECGs after treatment |
30 days post study drug administration
|
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Changes in blood pressure by dose group and BMI (kg/m^2)
기간: 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)
기간: 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
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Changes in pulse oximetry by dose group and BMI (kg/m^2)
기간: 30 days post study drug administration
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Comparison of post treatment changes in pulse oximetry by dose group and BMI (kg/m^2) |
30 days post study drug administration
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Physician Satisfaction
기간: 10 Minutes post study drug administration
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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™."
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10 Minutes post study drug administration
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Time to visualization
기간: 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
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Michelle Boytim, Ph.D., Provepharm SAS
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PVP-22IC04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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