ObesityNAVICAMNCT07587437
Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery
A study of Obesity and Bariatric Surgery Candidate, run by Jerry Dang at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Hypertension
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery: A Feasibility Prospective Trial
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.
Read more
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.
Read the 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.
- Conditions
- Obesity, Bariatric Surgery Candidate, Hypertension, Diabetes
- Being tested
- Magnetically Controlled Capsule Endoscopy (MCCE)
- Keywords
- Bariatric surgery, Preoperative testing, Roux-en-Y Gastric bypass, Sleeve gastrectomy
- Medical subject headings
- Obesity, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Magnetically Controlled Capsule Endoscopy (MCCE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
Secondary outcomes (2)
Number of Participants with Device Failure
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.
Measured: 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
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.
Measured: From enrollment to 14-21 days post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerry Dang
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, AnX Robotica Corp.
- Responsible party
- Sponsor-investigator, Jerry Dang, The Cleveland Clinic
- Investigators
- Jerry Dang, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587437
- Sponsor's protocol ID
- 24-365
- Acronym
- NAVICAM
- Status last verified
- May 2026
- First submitted
- 21 Jan 2025
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 38230854
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery: A Feasibility Prospective Trial
- ClinicalTrials.gov ID
- NCT07587437
- Acronym / sponsor ID
- NAVICAM / 24-365
- Conditions
- Obesity, Bariatric Surgery Candidate, Hypertension, Diabetes
- Keywords
- Bariatric surgery, Preoperative testing, Roux-en-Y Gastric bypass, Sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jerry DangUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, AnX Robotica Corp.
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnetically Controlled Capsule Endoscopy (MCCE) Arm | Experimental | Device: Magnetically Controlled Capsule Endoscopy (MCCE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Device | Magnetically Controlled Capsule Endoscopy (MCCE) Arm |
Primary outcome
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.
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
Time frame: 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
Time frame: 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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 38230854Scott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerry Dang, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity and Bariatric Surgery Candidate, run by Jerry Dang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07587437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.