Набор скоро начнётся NCT07004439

A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice

Без фазы С лечением Gastroesophageal Reflux Disease

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: RefluxStop™ implantation.
Кому может быть актуально: Состояния в реестре: Gastroesophageal Reflux Disease. Базовые параметры: от 18 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: Германия, Испания
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 Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice

Обзор

A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD. Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.

Вмешательства

Устройство RefluxStop™ implantation
Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use

Первичные конечные точки

Reduction of Patient Reported Outcome - Side effects (PROS) [Срок оценки: 1 year]

Вторичные конечные точки (2)

Incidence of safety events [Срок оценки: 3 and 6 months and years 1 to 7]
Reduction of Patient Reported Outcome - Side effects (PROS) [Срок оценки: 6 months and years 2 to 7]

Критерии участия

Критерии включения

Willing and able to provide informed consent and to participate in the registry study;
Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
24-hour pH or impedance pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be < 4 for ≥ 4.5% of total time during a 24-hour monitoring) and/or total reflux episodes >55 or weekly acid >26 for > 5 seconds, all measured 5 cm above LES);
Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Критерии исключения

Hiatal Hernia larger than 8 cm;
Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
History of bariatric surgery wherein the stomach fundus has been extirpated;
Female subjects who are pregnant;
Known sensitivity or allergies to silicone materials;
Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
Subjects that are unable to comply with the registry requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement).

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

Здоровые добровольцы: Нет