Using magnetic systems to assist in bariatric and general surgery
Bariatric, Revisional and General Surgery With Magnetic Assistance
This study is testing a new magnetic system to see if it can help surgeons during bariatric and general surgeries, making the procedures safer and more effective for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Unidad Internacional de Cirugia Bariatrica y Metabolica Academic / other |
| Locations | 1 site (Maracaibo, Zulia) |
| Trial ID | NCT04944810 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of a magnetic system as a second surgical assistant in various bariatric surgeries, including sleeve gastrectomy and gastric bypass. The magnetic device is intended to assist in tasks such as liver retraction and other surgical maneuvers, potentially improving surgical outcomes and aesthetics. The study will involve patients undergoing primary and revisional bariatric surgeries, as well as certain general surgical procedures, utilizing a single-port or port-reduced approach.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a BMI greater than 30 who are candidates for bariatric surgery or have conditions like GERD or gallstones.
Not a fit: Patients with pacemakers, uncontrolled metabolic diseases, or psychiatric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical precision and patient recovery in bariatric and general surgeries.
How similar studies have performed: While magnetic devices have been used in bariatric surgery, this specific application as a second surgical assistant is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years old * BMI Greater than 30 kg/m2 (Obesity) * Candidate to bariatric surgery * GERD * Candidate to revisional bariatric surgery * Cholecystitis or Gallstones (General Surgery) Exclusion Criteria: * Patients with pacemakers or electromedical implants * Uncontrolled metabolic diseases * Psychiatric problems
Where this trial is running
Maracaibo, Zulia
- Unidad Internacional de Cirugía Bariátrica y Metabólica — Maracaibo, Zulia, Venezuela (Recruiting)
Study contacts
- Principal investigator: Andres Maldonado, MD — International Unit of Bariatric and Metabolic Surgery
- Study coordinator: Guillermo Borjas, MD. PhD
- Email: drguillermoborjas@hotmail.com
- Phone: 4146863041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.