NaviCam Patency Capsule to Verify Gastrointestinal Patency (PATENCY)
2026年6月10日 更新者：AnX Robotica Corp.
A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency
Participants included in this study will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm weather the capsule is still in the body.
研究概览
详细说明
If the X-ray scan indicates that the capsule is not in the body or shows that the patency capsule is in the colonic area or if an intact patency capsule is found in the bowel movement, it proves that the intestine is patent, and the patient can undergo an examination using capsule endoscopy. If the X-ray scan shows that the capsule is still in the small bowel area, it indicates that there may be stricture(s) in the intestines, and then small bowel capsule endoscopy may not be performed.
The patency capsule is a disposable medical device composed of medicinal excipients in the shape of a dissolvable passive capsule and will dissolve over time if not excreted.
研究类型
介入性
注册 (估计的)
25
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Tim Thomas, RAC
- 电话号码：770-480-2911
- 邮箱：tim.thomas@anxrobotics.com
学习地点
-
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Illinois
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Downers Grove、Illinois、美国、60515
- Digestive Health Services
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接触：
- Rockford G Yapp, MD
- 电话号码：630-297-9474
- 邮箱：rockford.g.yapp3@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients with suspected or known intestinal stricture (with medical history records, physical examination records, and imaging evidence within the last 6 months.
- Patients suffering from Crohn's Disease
- Patients with long-term use of non-steroidal anti-inflammatory drugs.
- Patients with abdominal symptoms related to intestinal stricture.
- Patients with chronic inflammatory diseases.
- Patients with difficulty with balloon-assisted endoscopy (BAE).
- Patients with a history of small bowel obstruction.
- Patients with a history of intestinal resection surgery.
Exclusion Criteria:
- Patients with esophageal obstruction or swallowing disorder diseases.
- Patients who are ineligible for surgery or refuse to undergo any abdominal surgery.
- Patients with known allergies or other contraindications or intolerance to the medications used in this study.
- Patients with pacemakers or other implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, neurostimulators.
- Pregnant women
- Patients currently enrolled in another drug or device clinical trial.
- Other conditions deemed unsuitable for inclusion by the investigator.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Single arm patency capsule evaluation
Participants will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm whether the capsule is still in the body.
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The NaviCam Patency Capsule is an accessory to the NaviCam capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the NaviCam capsule in patients with known or suspected strictures.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety of patency capsule
大体时间：30 hours
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The number of patients successfully passing the Patency Capsule within 30 hours compared to the number of patients where the Patency Capsule dissolves in patients with strictures.
|
30 hours
|
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Efficacy of patency capsule
大体时间：30 hours
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The percentage of patients that successfully pass the Patency capsule within 30 hours.
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30 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rockford G Yapp, MD、Digestive Health Services
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Herrerias JM, Leighton JA, Costamagna G, Infantolino A, Eliakim R, Fischer D, Rubin DT, Manten HD, Scapa E, Morgan DR, Bergwerk AJ, Koslowsky B, Adler SN. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc. 2008 May;67(6):902-9. doi: 10.1016/j.gie.2007.10.063. Epub 2008 Mar 19.
- Takeda K, Tashimo H, Miyakawa K, Shimada M, Ohshima N, Tamura A, Nagai H, Matsui H. Patency Capsule Aspiration. Intern Med. 2020 Apr 15;59(8):1071-1073. doi: 10.2169/internalmedicine.4012-19. Epub 2020 Jan 9.
- Okoli A, Ammannagari N, Mazumder M, Nakkala K. When the dissolvable does not dissolve: an agile patency capsule mystery. Am J Gastroenterol. 2014 Apr;109(4):605-7. doi: 10.1038/ajg.2013.435. No abstract available.
- Mitselos IV, Katsanos K, Tsianos EV, Eliakim R, Christodoulou D. Clinical Use of Patency Capsule: A Comprehensive Review of the Literature. Inflamm Bowel Dis. 2018 Oct 12;24(11):2339-2347. doi: 10.1093/ibd/izy152.
- Spada C, Shah SK, Riccioni ME, Spera G, Marchese M, Iacopini F, Familiari P, Costamagna G. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol. 2007 Jul;41(6):576-82. doi: 10.1097/01.mcg.0000225633.14663.64.
- Kopylov U, Nemeth A, Cebrian A, Wurm Johansson G, Thorlacius H, Fernandez-Urien Sainz I, Koulaouzidis A, Eliakim R, Toth E. Symptomatic retention of the patency capsule: a multicenter real life case series. Endosc Int Open. 2016 Sep;4(9):E964-9. doi: 10.1055/s-0042-112588. Epub 2016 Aug 8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2026年12月15日
研究完成 (估计的)
2027年3月15日
研究注册日期
首次提交
2026年5月24日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月10日
最后验证
2026年6月1日
更多信息
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