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.
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Head of Clinical Affairs
- 電話番号：+45 93 56 40 00
- メール：contact@optheras.com
研究場所
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Herlev、デンマーク、2730
- 募集
- Herlev Hospital, Department of Urology
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コンタクト：
- Pedersen
- 電話番号：+45 38 68 01 48
- メール：heh-urologisk.afdeling.h@regionh.dk
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distance sensing of bladder tumor tissue
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Distance sensing of normal bladder tissue
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Guide beam visibility
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CIV-26-06-058854
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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