Идёт набор NCT06915818

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

Без фазы С лечением Colon Anastomosis

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: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc.
Кому может быть актуально: Состояния в реестре: Colon Anastomosis. 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 Ileo-colic and Colo-colonic 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Вмешательства

Устройство Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of co

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 surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) 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
All cancer patients must have completed chemotherapy ≥2 months prior to 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 that may suggest difficulty during endoscopic delivery of magnets
Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
History of recurrent small bowel obstructions.
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
Congestive heart failure with ejection fraction <35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
Decompensated chronic obstructive lung disease
Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
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
Contraindication to general anesthesia
Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator