Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
調査の概要
詳細な説明
Following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. Others may be incontinent of urine. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used, or a condom-type urine collection device. These may be associated with skin irritation and infection.
The study will evaluate the UriCap-RM non-invasive urine collection device in hospitalized men.
研究の種類
入学 (予想される)
段階
- 適用できない
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:
- Male ≥ 18 years old.
- Empties the bladder completely on voiding
- A clinical indication for an indwelling catheter, use of pads or diapers
- Subject has signed an informed consent form, is cooperative and willing to complete all study procedures
- Absence of localized disease at the site of device application - no discharge, itching, inflammation or skin condition - - on visual examination
- Subject has no hypersensitivity to silicon.
Exclusion Criteria:
- Known allergy to silicon
- Dysuria
- Urinary retention - Post-void residual urine more than 300cc
- Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
- Diagnosed with acute renal failure, according to investigator judgement.
- Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the subject's well-being or successful participation in the study
- Participating in another clinical study.
- Financial interest in the Sponsor Company or a competitor company by subject or a family member
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：支持療法
- 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 |
|---|---|
|
実験的：UriCap-RM
The device is comprised of a reusable part and a single use adhesive tape.
The device is removed once daily and the reusable part is rinsed, dried and reapplied with a new adhesive tape.
|
UriCap-RM is comprised of a reusable part and a single use adhesive tape.
The reusable part is applied over the urethral meatus and is held in position by a stabilizer and adhesive tape.
It is connected to a standard urine collection bag.
The UriCap-RM is used on male patients who would otherwise use diapers, a condom-type urine collection device or an indwelling catheter for urine collection.
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 |
|---|---|---|
|
Performance of the device in collecting urine
時間枠：1-30 days
|
Multiple variables will be assessed and their measurements aggregated to arrive at number of events reported:
|
1-30 days
|
|
Patient Comfort
時間枠：1-30 days
|
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
|
1-30 days
|
|
Healthcare provider (HCP) satisfaction in device use
時間枠：up to 60 days
|
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
|
up to 60 days
|
|
Patient Satisfaction in Device Use
時間枠：1-30 days
|
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
|
1-30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effectiveness of defined device cleaning procedure
時間枠：1-30 days
|
The reusable part will be visually inspected after cleaning for suitability for reuse.
Devices which exhibit any of the following properties will be discarded: color change, residual soiling, loss of mechanical integrity, torn, rough edges.
The effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
|
1-30 days
|
|
Number of leakage events resulting from device movement
時間枠：1-30 days
|
1-30 days
|
|
|
Number of patients with Adverse Events that are related to device use
時間枠：1-30 days
|
1-30 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Elad Schiff, MD、No Affiliation
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。