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New treatment option for Gastric Anastomosis (Site)
Official title Magnet Anastomosis in Patients Undergoing Gastric Surgery
ClinicalTrials.gov ID: NCT06915337
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Huechuraba, Región Metropolitana, Chile
- Indore, Madhya Pradesh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Huechuraba, Región Metropolitana, Chile; Indore, Madhya Pradesh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.