Bariatric Surgery Candidate, Diabetes, Hypertension, Obesity
Conditions
Keywords
Bariatric surgery, Preoperative testing, Roux-en-Y Gastric bypass, Sleeve gastrectomy
Brief summary
The goal of this clinical trial is to test if a swallowable camera capsule can safely examine the upper digestive tract in people preparing for weight loss surgery. The camera capsule (called NaviCam® Xpress™ Stomach System) is controlled by magnets from outside the body and doesn't require sedation, unlike traditional endoscopy. The main questions it aims to answer are: Can the camera capsule be safely used in people with a body mass index (BMI) greater than 38? Can doctors successfully control and move the camera capsule to see the necessary areas of the stomach and esophagus? Researchers will evaluate 30 participants who are preparing for weight loss surgery. Participants will: Swallow the camera capsule with water after not eating or drinking since midnight Have their upper digestive tract examined while the doctor controls the capsule from outside their body Complete a brief satisfaction survey about their experience Be followed up with a phone call 2-3 weeks after the procedure This study could help determine if the camera capsule is a good alternative to traditional endoscopy for people preparing for weight loss surgery, potentially avoiding the need for sedation.
Detailed description
Detailed Description: The NaviCam® Xpress™ Stomach System represents a novel approach to upper gastrointestinal visualization in the bariatric surgery population. This magnetically controlled capsule endoscopy (MCCE) system consists of a single-use wireless capsule that contains imaging components and magnetic materials that allow external control through a physician-operated magnet. Technical Specifications and Procedure: The capsule is equipped with cameras capable of capturing both still images and continuous video footage. After the patient swallows the capsule with 500ml of water, it initially descends the esophagus via natural peristalsis while continuously recording. The capsule is initially attached to a tether, which is released via a 15ml air injection mechanism once the capsule reaches the appropriate position. Once inside the stomach, the external magnetic control system allows the physician to systematically manipulate the capsule's position and orientation, enabling thorough visualization of the gastric mucosa. Clinical Significance: This study addresses a critical gap in pre-bariatric surgery evaluation. While traditional esophagogastroduodenoscopy (EGD) remains the gold standard, it presents unique challenges in the bariatric population due to: Increased sedation risks associated with high BMI Higher technical complexity of the procedure Greater risk of respiratory complications during sedation Innovation and Technological Advancement: This represents one of the first applications of MCCE technology specifically targeted at the bariatric surgery population. The study's focus on patients with BMI \>38 kg/m² will provide valuable data about the system's performance in body habitus previously considered challenging for magnetic control systems. The feasibility assessment incorporates multiple technical parameters: Magnetic control responsiveness across varying body habitus Quality of mucosal visualization in different anatomical regions System reliability and technical performance metrics Procedure duration and technical success rates This study will help establish the potential role of MCCE in the standard pre-bariatric surgery evaluation pathway and may inform future technological refinements specific to this patient population.
Interventions
The intervention consists of a wireless capsule containing cameras and magnetic materials that enable external control. After overnight fasting, participants swallow the capsule with 500ml of water. The capsule is initially tethered and captures images as it descends the esophagus. Once appropriately positioned, the tether is released by injecting 15ml of air. A trained surgeon then controls the capsule's movement within the stomach using an external magnetic control system, allowing systematic visualization of the upper gastrointestinal tract mucosa. The procedure is performed without sedation and takes place at the Main Campus M60 facility. The capsule naturally passes through the digestive system after the examination.
Sponsors
Jerry Dang
The Cleveland Clinic
AnX Robotica Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The study will enroll 30 consecutive eligible patients who are preparing for bariatric surgery. This sample size was specifically chosen based on current recommendations in the literature for pilot feasibility studies. All participants will undergo the same MCCE procedure using the NaviCam® Xpress™ Stomach System at the Main Campus M60 facility.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Diagnosed with morbid obesity * Undergoing primary bariatric surgery by current international guidelines * BMI greater than 38 kg/m² and less than or equal to 65 kg/m² * Waist circumference less than or equal to 77 inches
Exclusion criteria
* Patients with permanent pacemakers and other surgically placed metallic devices which function can interfere with the magnetic field * Patients with dysphagia and those who are at risk of capsule retention (gastric outlet obstruction, intestinal stenosis, inflammatory bowel disease, previous abdominal surgeries with suspicious of adhesive bowel disease) * Patients with reported upper gastrointestinal symptoms who would require a conventional EGD * Patients currently participating in other clinical studies * Patients who do not speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Successful Magnetic Control of the Capsule | From enrollment to the end of interpretation of the MCCE images, approximately 20 days. | Successful magnetic control is defined as the ability of the NaviCam Xpress Stomach System to be moved as intended and controlled by the surgeon to all target anatomical regions. Reported as the number of participants in whom successful magnetic control was achieved. |
| Number of Participants with Adequate Visualization of the Esophageal and Gastric Mucosa | From enrollment to the end of interpretation of the MCCE images, approximately 20 days. | Adequate visualization is defined as the NaviCam Xpress Stomach System providing satisfactory imaging of the esophageal and gastric mucosa as assessed by the operating surgeon. Reported as the number of participants in whom adequate visualization was achieved. |
| Number of Participants Completing MCCE Without Conversion to Conventional Endoscopy | From enrollment to the end of interpretation of the MCCE images, approximately 20 days. | Defined as successful completion of the magnetically controlled capsule endoscopy procedure without the need for conversion to a conventional esophagogastroduodenoscopy (EGD). Reported as the number of participants who completed the procedure without conversion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Device Failure | From enrollment to the end of interpretation of the MCCE images, approximately 20 days. | Defined as device breakage or malfunction requiring additional surgical intervention, including reoperation and/or device removal. Reported as the number of participants experiencing device failure. |
| Number of Participants with Serious Adverse Events Probably or Definitely Related to the Device | From enrollment to 14-21 days post-procedure. | Defined as any serious adverse event probably or definitely related to the device, including revision or removal of the device, permanent damage to the organ, or death of the study subject. Reported as the number of participants experiencing a device-related serious adverse event. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJerry Dang, MD, PhD
The Cleveland Clinic
Outcome results
None listed