임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07395492은(는) Bowel Preparation Solution에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
App-Based Education and Low-Residue Diet for Colonoscopy Preparation 420 무작위 배정 식이 요법
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07395492은(는) Bowel Preparation Solution에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 3월 1일부터 참여 신청이 가능합니다. 420명의 참여자를 모집할 예정입니다. Chang Gung Memorial Hospital이(가) 진행하는 이 연구는 2026년 10월 21일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 9일에 갱신되었습니다.
간단한 개요
This prospective, randomized, evaluator-blind, parallel-group trial is designed to objectively compare the effectiveness of Advanced Bowel Preparation versus Traditional Bowel Preparation in patients undergoing colonoscopy. In this study, "naive patients" are defined as individuals who have never used Bowklean® as a bowel cleansing agent, or those who may have previously used other bowel preparation regimens but have...더 보기
상세한 설명
Bowel preparation is a important task for colonoscopy examination. Studies have demonstrated that using smartphone apps can improve patient compliance and the quality of bowel cleansing. Additionally, the use of prepackaged low residue diet (PLD) has become increasingly common. PLD are designed to minimize undigested food residue in the gut, facilitating a cleaner colon for procedures like colonoscopy. Implementing P...더 보기
공식 제목
Impact of App-Based Education and Low-Residue Diet Approaches on Colonoscopy Preparation in Naive Patients: A Randomized, Evaluator-Blind Controlled Trial
질환명
Bowel Preparation Solution기타 연구 식별자
- 202501149B0
NCT 번호
실제 연구 시작일
2026-03-01
최신 업데이트 게시
2026-02-09
예상 연구 완료일
2026-10-21
계획된 등록 인원
420
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Bowklean
Bowel preparation
Low-residue diet
boston bowel preparation scale
Bowel preparation
Low-residue diet
boston bowel preparation scale
주요 목적
진단
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
비개입Traditional Bowel Preparation The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low-residue dietary restrictions. | 해당 없음 |
실험적Advanced Bowel Preparation Advanced Bowel Preparation integrates a smartphone-based educational app (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD). | Tian Tian Yi Chi go APP (developed by UIC Corp) Bowl preparation educational app Prepackaged Low-Residue Diet Prepackaged Low-Residue Diet |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Percentage of subjects that achieve adequate cleansing | The percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS) | Day1 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The percentage of subjects that achieve excellent cleansing | (score ≧ 8) in the Boston Bowel Preparation Scale (BBPS). | Day1 |
Mean score in different colon segments | right, transverse, left colon segmental subscore, which are assessed with the BBPS. | Day1 |
Adenoma Detection Rate (ADR) | Proportion of patients in whom at least one adenoma is detected during the colonoscopy. | Day14 |
Sessile Serrated Polyp (SSP) Detection Rate | Proportion of patients in whom at least one SSP is detected during the colonoscopy. | Day14 |
Patient Satisfaction | Satisfaction will be evaluated in three subcategories through a questionnaire:
1. Bowel cleansing agent: Assessing the experience and acceptability of using Bowklean.
2. Dietary restrictions: Evaluating satisfaction with the assigned low-residue dietary approach (PLD or self-prepared).
3. APP Satisfaction: For groups assigned to APP utilization, assessing the APP's ease of use, functionality, and perceived utility. | Day1 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Male or female 18 to 75 years of age.
- Bowklean naive patient with no bowel preparation in 3 years.
- The subject is scheduled for a colonoscopy.
- Ability to complete the entire procedure and to comply with study instructions.
- Willingness and ability to provide signed informed consent.
1. Patients who are unsuitable for Bowklean use due to known contraindications, including but not limited to:
- Allergies or hypersensitivity to Bowklean or its ingredients.
- Severe gastrointestinal conditions (e.g., obstruction, perforation).
- Renal impairment or electrolyte imbalances (e.g., severe hyponatremia).
- Gastrointestinal surgery affects bowel preparation. 2. Patients deemed medically unsuitable for colonoscopy by the physician. 3. Cognitive, language, or other barriers that prevent completion of the questionnaire.
4. Non-compliance with the bowel preparation protocol or inability to follow dietary restrictions (e.g., Prepackaged low residue diet, PLD).
5. Inability to use or access the mobile APP (e.g., no smartphone, unfamiliarity with APP operations, or technical limitations).
6. Participation in other clinical trials.
Chang Gung Memorial HospitalUniversal Integrated Corp.연구 책임자
Chen-Ming Hsu, 책임연구자, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital
연락처 정보가 없습니다.