Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors (LUMINA I)
An In-vivo Feasibility Study of Laser-based Automatic Irradiance Control in Persons With Superficial Bladder Tumors
The goal of this clinical investigation is to test the sensing and guiding part of the ATLAS system in the human bladder of people with Ta low grade bladder tumors.
The main questions it aims to answer are:
Does the distance sensor of the ATLAS system work as well on human bladder tumor tissue as in normal pig bladder tissue? Does the distance sensor of the ATLAS system work as well on normal human bladder tissue as in normal pig bladder tissue?
Participants will be asked to have their scheduled outpatient laser treatment of bladder tumor(s), detected during surveillance cystoscopy, expanded by approximately 5 minutes.
연구 개요
상세 설명
The primary purpose is designated as 'Other' because this is a traditional feasibility investigation evaluating initial clinical safety and performance in 25 subjects to support a future pivotal investigation. The investigation is conducted in EU (Denmark).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Head of Clinical Affairs
- 전화번호: +45 93 56 40 00
- 이메일: contact@optheras.com
연구 장소
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Herlev, 덴마크, 2730
- 모병
- Herlev Hospital, Department of Urology
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연락하다:
- Pedersen
- 전화번호: +45 38 68 01 48
- 이메일: heh-urologisk.afdeling.h@regionh.dk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- People with bladder tumor(s) detected during surveillance cystoscopy and booked for outpatient laser treatment of the tumor(s)
Exclusion Criteria:
- Macroscopic hematuria
- Pregnant or breastfeeding women
- Expected poor compliance
- Dementia
- Persons under 18 years of age
- Persons who do not read or understand Danish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention: ATLAS system
The participants are patients booked for outpatient laser treatment of superficial bladder tumors. The planned laser treatment will be performed through a flexible cystoscope. Normal treatment procedure is initiated with a cystoscopy to identify tumors. The investigation intervention will be performed after the cystoscopy by inserting a catheter including the ATLAS laser fiber. Measurements on bladder tumors and normal tissue will be performed. The normal treatment procedure will take place subsequent to the investigation procedure. The investigation procedure will prolong the planned laser treatment with approximately 5 minutes. A follow-up telephone call will be conducted after 7-10 days to interview the participants regarding adverse events. The number of participants to be enrolled is set at 25 to account for dropouts due to, e.g., a urinary tract infection on the day of the procedure. This size was chosen to ensure that 20 participants complete according to protocol. |
This version of the ATLAS system is aimed at evaluating a distance sensor and a guide beam. The version of the ATLAS system developed for this investigation does not contain a treatment laser.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Distance sensing of bladder tumor tissue
기간: At baseline visit
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ATLAS-010-110-L1A distance range measured on tumor tissue. The distance range is defined as the longest distance the system can detect in a 10 second period of continuous measurement. Range is a measure of both the reflection properties of the tissue and the quality of the detection by the sensor. If flat papillary tumor tissue is present in the bladder, the measurement will be performed on this tissue. The range measured on bladder tumor tissue in humans is compared to the range previously measured in pigs on normal bladder tissue during in-vivo experiments to test whether human bladder tumor tissue reflects the sensor's light well enough for the system to detect it from as far away as it could detect normal bladder tissue in pigs. |
At baseline visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distance sensing of normal bladder tissue
기간: At baseline visit
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ATLAS-010-110-L1A distance range measured on normal bladder tissue. The range measured on normal bladder tissue in humans is compared to the range previously measured in pigs during in-vivo experiments. |
At baseline visit
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Guide beam visibility
기간: At baseline visit
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Structured feedback on the functionality of the guide beam is collected through a questionnaire answered by the physician after each procedure. The questionnaire collects feedback on the light intensity of the guide beam on different distances from the bladder wall. A video of the guide beam function is recorded by the cystoscope. |
At baseline visit
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CIV-26-06-058854
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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