Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery (NAVICAM)
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.
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Magnetically Controlled Capsule Endoscopy (MCCE) Arm
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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Successful Magnetic Control of the Capsule
時間枠：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.
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From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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Number of Participants with Adequate Visualization of the Esophageal and Gastric Mucosa
時間枠：From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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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.
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From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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Number of Participants Completing MCCE Without Conversion to Conventional Endoscopy
時間枠：From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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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.
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From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants with Device Failure
時間枠：From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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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.
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From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
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Number of Participants with Serious Adverse Events Probably or Definitely Related to the Device
時間枠：From enrollment to 14-21 days post-procedure.
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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.
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From enrollment to 14-21 days post-procedure.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jerry Dang, MD, PhD、The Cleveland Clinic
出版物と役立つリンク
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一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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