ISRCTN42273449已完成未知
A multicentre pragmatic clinical investigation to assess the efficacy of TransiCap MRI marker device in magnetic resonance imaging in paediatric constipation (MAGIC2)
ottingham University Hospitals NHS Trust0 个研究点目标入组 436 人开始时间: 2020年4月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 436
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33093366/ (added 08/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children aged 7 – 18 years old
- •2. Able to give assent/consent or have a parent/carer able to give informed consent
- •3. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation
- •4. Children diagnosed with clinical diagnosis of constipation
排除标准
- •1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self-reported
- •2. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as colectomy or small bowel resection
- •3. Existing ACE procedure before the first MRI scan
- •4. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- •5. Inability to lie flat and relatively still for less than 5 minutes
- •6. Poor understanding of English language
- •7. The following disease or disorder: bowel stricture disease, Crohn’s or any difficulty in swallowing (dysphagia), Hirschsprung disease, congenital anorectal malformations, paediatric pseudo-obstruction syndrome
- •8. Currently using the following drugs influencing drug motility:
- •8.1. Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramoland)
- •8.2. Antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide)
- •9. Participants who have participated in another research clinical investigation involving an investigational product in the past 12 weeks.
- •10. 4 or more bowel movements in one week and no episodes of bowel incontinence in one week (if these are reported in the participant’s medical notes. Absence of this information should not warrant exclusion)
研究者
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