NCT01370928已完成3 期
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Sorlandet Hospital HF2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Patients´ evaluation of pain and discomfort
研究概览
简要总结
The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 54 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons included in the NordICC trial are eligible for inclusion
- •For information about the NordICC trial see clinicaltrials.gov NCT00883792
排除标准
- •Pregnancy
- •Persons younger than 18 years
- •Persons unable to comprehend the information given
- •not possible to start the examination without prior administration of sedation/analgesics
结局指标
主要结局
Patients´ evaluation of pain and discomfort
时间窗: 24 hours
Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.
次要结局
- Need for sedation/analgesics during the colonoscopy procedure(1 hour)
- Time used to reach the caecum(1 hour)
- Need to change to a different colonoscope to complete the procedure(10 minutes)
- Caecum intubation rate(30 minutes)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Trial on Innovative Technologies in ColonoscopyPolypsNeoplasmsInflammatory Bowel DiseaseNCT01688557Jagiellonian University600
已完成
不适用
Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & CholangitisColitis, UlcerativeCholangitis, SclerosingNCT00587236Mayo Clinic65
已完成
不适用
Efficacy of a novel colonoscope for colorectal polyp detectiocolorectal lesionsJPRN-UMIN000011624Hiroshima University Hospital300
进行中（未招募）
不适用
Extra Wide Field of View Lens StudyColonic PolypNCT06483503Pentax Medical60
已完成
不适用
Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric ColonoscopeColonoscopyNCT03807089Massachusetts General Hospital283