Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery

NCT07587437 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-365
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Bariatric Surgery Candidate; Hypertension; Diabetes

Keywords

Bariatric surgery; Preoperative testing; Roux-en-Y Gastric bypass; Sleeve gastrectomy

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Successful Magnetic Control of the Capsule

  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.

  From enrollment to the end of interpretation of the MCCE images, approximately 20 days.

• Number of Participants with Adequate Visualization of the Esophageal and Gastric Mucosa

  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.

  From enrollment to the end of interpretation of the MCCE images, approximately 20 days.

• Number of Participants Completing MCCE Without Conversion to Conventional Endoscopy

  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.

  From enrollment to the end of interpretation of the MCCE images, approximately 20 days.

Secondary Outcomes (2)

• Number of Participants with Device Failure

  From enrollment to the end of interpretation of the MCCE images, approximately 20 days.

• Number of Participants with Serious Adverse Events Probably or Definitely Related to the Device

  From enrollment to 14-21 days post-procedure.

Study Arms (1)

Magnetically Controlled Capsule Endoscopy (MCCE) Arm

EXPERIMENTAL

Participants will undergo preoperative upper gastrointestinal tract evaluation using the NaviCam® Xpress™ Stomach System, a magnetically controlled capsule endoscopy device. After fasting overnight, participants will swallow the capsule with 500ml of water. The capsule will initially be tethered and will capture images as it descends the esophagus. Once positioned appropriately, the tether will be released via 15ml air injection, and the surgeon will control the capsule's movement in the stomach using an external magnetic control system. All participants will be followed for 14-21 days post-procedure.

Device: Magnetically Controlled Capsule Endoscopy (MCCE)

Interventions

Magnetically Controlled Capsule Endoscopy (MCCE) DEVICE

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.

Magnetically Controlled Capsule Endoscopy (MCCE) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jerry Dang: lead
• The Cleveland Clinic: collaborator
• AnX Robotica Corp.: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Scott J, Blackhurst D, Hodgens BD, Carbonell AM, Cobb WS, Richardson ES, Dahlgren NJ, Kothari SN. Use of Preoperative Endoscopic Capsule-Based pH Testing Before Bariatric Surgery. J Am Coll Surg. 2024 Apr 1;238(4):551-558. doi: 10.1097/XCS.0000000000000974. Epub 2024 Mar 15.

  PMID: 38230854 RESULT

MeSH Terms

Conditions

Obesity; Hypertension; Diabetes Mellitus

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jerry Dang, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: May 14, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)