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Набор скоро начнётся NCT07649720

NaviCam Patency Capsule to Verify Gastrointestinal Patency

Без фазы С лечением Intestinal Stricture Crohn Disease NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy Abdominal Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NaviCam Patency Capsule.
Кому может быть актуально
Состояния в реестре: Intestinal Stricture, Crohn Disease, NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy, Abdominal Pain. Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство NaviCam Patency Capsule
    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.

Первичные конечные точки

  • Safety of patency capsule [Срок оценки: 30 hours]
  • Efficacy of patency capsule [Срок оценки: 30 hours]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Digestive Health Services — Downers Grove

Публикации

  • 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. PMID 31915319
  • 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. PMID 24698874
  • 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. PMID 29718225
  • 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. PMID 17577114
  • 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. PMID 18355824
  • 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. PMID 27652302

Идентификаторы

NCT: NCT07649720 · P11_CEP-0001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗