Remote Manipulation of a Capsule Endoscope (Remote capsule)

Tracking Information
First Submitted Date	January 7, 2010
First Posted Date	January 8, 2010
Last Update Posted Date	January 8, 2010
Study Start Date	April 2008
Actual Primary Completion Date	April 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Remote Manipulation of a Capsule Endoscope
Official Title	Remote Manipulation of a Capsule Endoscope in the Esophagus and Stomach of a Human Volunteer Using an External Hand-held Magnet
Brief Summary	The purpose of the study is to learn about the feasibility of moving a pill-sized camera (Givens Capsule) remotely in the esophagus and stomach using an external hand held magnet.
Detailed Description	Magnetic remote manipulation: A simple and inexpensive method for manipulation of capsule endoscopes has been developed and successfully tested in survival studies in pigs. This has involved modifications of capsules which are in clinical use in patients as follows. One of the two imagers in esophageal capsules have been removed and replaced with three small magnets which are fixed within the capsule casing. This does not alter the dimensions of the capsule which can be reconstituted in a conventional casing. The magnetic reed switch which turns the capsule on and off is removed and is replaced with a thermal switch which will turn the capsule on if placed in hot water above 60 degrees centigrade for 60 seconds. The capsule can be manipulated using an external hand held paddle shaped magnet measuring approximately 20 x 20 x 5 centimeters which is held and rotated close to the back of the subject when the modified capsule is in the esophagus or the anterior abdominal wall when the capsule is in the stomach. The magnets used are of neodymium iron boron (quaternary ion magnets). The capsules are modified from FDA approved devices by Given Imaging (the company that makes these capsules). The outside of the capsule is unchanged but internal modifications, the changing of the switch and the inclusion of the magnet, are not FDA approved and are experimental. Planned experiment in a human volunteer: This study is for one, currently identified healthy volunteer only. The volunteer for this study is one of the inventors of the capsule endoscope technology (Paul Swain, MD) Dr. Swain will be consented in the usual manner with the current IRB approved consent. Dr. Rothstein will perform a physical exam to ensure that he is in general good health, has no esophageal or bowel disease or conditions that would contraindicate participation in the present study. He will then swallow a magnetically modified capsule as follows. He will be fasted overnight for the experiment which will be conducted in the designated endoscopy unit following standard endoscopic practise. A cannula will be placed for suitable intravenous access if needed, and D5/half normal saline infused to keep the vein open. The experiment will be performed with no sedation if possible or light sedation using benzodiazepines and/or narcotics (standard medications for endoscopy) at the discretion of the principal investigator and the volunteer. Topical anesthetics will be applied in the customary fashion for upper endoscopy. The volunteer will lie in the left lateral position and will swallow the capsule in a recumbent posture and may aid swallowing by sipping water from a glass through a straw. A flexible endoscope will be passed into the esophagus by the endoscopist. Another person who is not the endoscopist will manipulate the external paddle-shaped magnet. This involves moving and rotating the polarities of this magnet adjacent to the back and abdomen of the volunteer. A real-time viewer displaying images obtained from the capsule will be placed in a position so both the endoscopist and the paddle-magnet manipulator can view and react to the images. The images from the flexible endoscope, room images showing the movements of the paddle magnet and the real-time images acquired from the capsule will be recorded. The volunteer will be asked to indicate if he can feel the magnet moving the capsule in the esophagus and stomach and whether it is at all painful (real-time and via follow-up visual analog scale - pain 1 to10, 1 no pain and 10 worst pain). The capsule will be manipulated in the esophagus and stomach with both flexible endoscopic and real time capsule imaging. Once manipulations in the esophagus have been completed the volunteer will be elevated (tilt table, sit or stand) to see if the magnet can hold the capsule in the esophagus against gravity. The capsule will then be allowed to pass into the stomach where it will be magnetically manipulated. Once the examination is completed the capsule will be removed using a Roth snare, a standardly employed accessory with a net which can be closed over objects for retrieval and is commonly used for polyp retrieval.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	One Human Volunteer, Healthy
Condition	Healthy
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: January 7, 2010)	1
Original Actual Enrollment	Same as current
Actual Study Completion Date	April 2008
Actual Primary Completion Date	April 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Asymptomatic adult volunteer with previously determined normal esophagus and stomach who understands the risks of the procedure. Exclusion Criteria: Known strictures in the intestine,; Crohn's disease,; Swallowing difficulty,; Age less than 21,; Age over 75 or have a pacemaker,; Presence of implanted metal devices,; Presence of esophageal or bowel disease or conditions that may preclude study participation as a matter of clinical judgment.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT01044797
Other Study ID Numbers	Given Imaging DHMC
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Richard Rothstein, MD, Dartmouth-Hitchcock Medical Center
Study Sponsor	Dartmouth-Hitchcock Medical Center
Collaborators	Given Imaging
Investigators	Principal Investigator: Richard I Rothstein, MD Dartmouth-Hitchcock Medical Center
PRS Account	Dartmouth-Hitchcock Medical Center
Verification Date	January 2010