Inflammatory Bowel Disease, Small Bowel Disease
Conditions
Keywords
capsule endoscopy, small bowel disease, inflammatory bowel disease, Subjects indicated for EGD endoscopy
Brief summary
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
Detailed description
Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope. The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies. Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section. This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy
Interventions
DEVICEPillCam® Express Capsule Endoscopy Delivery System
The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts: a catheter, a syringe and the capsule holder. The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device. The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter. Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded. The PillCam® Express Capsule Endoscopy Delivery System is single-use, disposable and latex-free.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Investigator)
Intervention model description
To evaluate the safety and efficacy of an endoscopic capsule placement device.
Eligibility
Sex/Gender
ALL
Age
2 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 2 years * Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel
Exclusion criteria
* Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation * Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure) * Presence of an electro-medical device (pacemaker or internal cardiac defibrillator) * Subject is pregnant * Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule * Subject has known allergy to conscious sedation medications * Subject or legal guardian is not able to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System | up to 7 days | The number of capsules that successfully were in the duodenum as indicated by video images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Subjective Assessment of the Ease of Capsule Placement | 7 days | The physician was required to assess the ease of use while answering a designated questionnaire. In addition, qualitative analysis was reformed with regard to all the open questions. |
Countries
United States
Participant flow
Recruitment details
3 hospital sites
Participants by arm
| Arm | Count |
|---|---|
| PillCam Express Capsule Delivery System PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | PillCam Express Capsule Delivery System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 18.3 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
The number of capsules that successfully were in the duodenum as indicated by video images
Time frame: up to 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pillcam Express Capsule Delivery System | Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System | 25 participants |
Secondary
Physician's Subjective Assessment of the Ease of Capsule Placement
The physician was required to assess the ease of use while answering a designated questionnaire. In addition, qualitative analysis was reformed with regard to all the open questions.
Time frame: 7 days
Population: Physicians completed questionnaires for each of the 25 subjects. The questions were divided to two: physicians assessment A where 'YES' is associated with a smooth procedure (4 questions x 25 subjects = 100 Y/N assessments) and physicians B where 'no' is associated with smooth procedure (6 questions x 25 subjects = 150 Y/N assessment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pillcam Express Capsule Delivery System | Physician's Subjective Assessment of the Ease of Capsule Placement | Physician Assessment A | 94 assessments |
| Pillcam Express Capsule Delivery System | Physician's Subjective Assessment of the Ease of Capsule Placement | Physician Assessment B | 126 assessments |