Идёт набор NCT06915337

Magnet Anastomosis in Patients Undergoing Gastric Surgery

Без фазы С лечением Gastric Anastomosis (Site)

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: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc.
Кому может быть актуально: Состояния в реестре: Gastric Anastomosis (Site). 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: Чили, Индия
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

GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures

Обзор

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.

Подробное описание

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating gastric-jejunal anastomoses in patients undergoing gastric surgery.

Вмешательства

Устройство Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of

Первичные конечные точки

Number of Participants with Successful Anastomosis Creation without the Need for Reoperation [Срок оценки: 30 Days]

Критерии участия

Критерии включения

Aged 22 years or older at screening
Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis with cardiac/medical clearance for surgery
Able to understand and sign informed consent document
American Society of Anesthesiologists (ASA) score < IV at time of procedure
Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
Able to refrain from smoking during study follow-up period

Критерии исключения

Known or suspected allergy to silicone, nickel, titanium or Nitinol
BMI > 55 kg/m2
Uncontrolled diabetes (defined as HbA1c >10%)
Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
Diagnosed with obstructed or perforated colon cancer
Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication
Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
Contraindication to general anesthesia
Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator