Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam® Express Capsule Endoscopy Delivery System | Device | 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 Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors.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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Leighton, MD | Mayo Clinic | Principal Investigator |
| Peter Legnani, MD | Private Practice New York, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Digestive Disorders Center, P. C. | Huntsville | Alabama | 35802 | United States | ||
| Alabama Liver and Digestive Specialists |
Not provided
3 hospital sites
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | up to 7 days |
|
|
Adverse Event information was collected from screening (up to -14 day prior to procedure) through follow up phone contact at 5-10 days after the procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| capsule failed to deploy in first attempt | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilla Debby/Director of clinical affairs | Givenimaging | 97249097774 | 7774 | hila.debby@givenimaging.com |
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
To evaluate the safety and efficacy of an endoscopic capsule placement device.
Not provided
Not provided
Not provided
| Montgomery |
| Alabama |
| 36116 |
| United States |
| RANY -Research Associates of New York (NY Gastroenterology Associates) | New York | New York | 10021 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | 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). | Posted | Number | assessments | 7 days | Y/N questions | Y/N questions |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
Not provided
Not provided
| Physician Assessment B |
|
|