Exploratory Investigation on a Novel Catheter - NAV-0010

Wellspect HealthCare0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•1. Provision of informed consent.
•2. Female and male aged 18 - 80 years.
•3. Patients successfully treated by TAI with Navina Smart system for at least 3
•months and/or stable in therapy.
•4. Able to read, write and understand information given to them regarding the

•1. Involvement in the planning and conduct of the clinical investigation
•(applies to both Wellspect HealthCare staff and staff at the study site).
•2. Previous enrolment in the present clinical investigation.
•3. Simultaneous participation in another clinical investigation, or
•participation in a clinical investigation during the last month, that may
•interfere with the present clinical investigation.
•4. Severe non-compliance to Clinical Investigation Plan as judged by the
•investigator and/or Wellspect HealthCare.
•5. Significant cardiovascular and/or other significant co-morbidities which
•could be negatively affected by the use of the investigational product.
•6. Known anal or colorectal stenosis.
•7. Active inflammatory bowel disease.
•8. Acute diverticulitis.
•9. Colorectal cancer.
•10. Ischemic colitis.
•11. Any anal or colorectal surgery within the previous 3 months.
•12. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4
•13. Any condition, as judged by the investigator, which might make follow-up or
•investigations inappropriate.
•14. Any patient that according to the Declaration of Helsinki is unsuitable for

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