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

Official title

Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery: A Feasibility Prospective Trial

Overview

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

• Device Magnetically Controlled Capsule Endoscopy (MCCE)
  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

Primary outcome measures

• Number of Participants with Successful Magnetic Control of the Capsule [Time frame: 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 [Time frame: From enrollment to the end of interpretation of the MCCE images, approximately 20 days.]
• Number of Participants Completing MCCE Without Conversion to Conventional Endoscopy [Time frame: From enrollment to the end of interpretation of the MCCE images, approximately 20 days.]

Secondary outcome measures (2)

• Number of Participants with Device Failure [Time frame: 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 [Time frame: From enrollment to 14-21 days post-procedure.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Cleveland Clinic Foundation — Cleveland

Publications

• 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

Identifiers

NCT: NCT07587437 · 24-365

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗