HealthyRemote capsuleNCT01044797
Remote Manipulation of a Capsule Endoscope
An observational study of Healthy, run by Dartmouth-Hitchcock Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: One Human Volunteer, Healthy
Who may be able to join
- Asymptomatic adult volunteer with previously determined normal esophagus and stomach who understands the risks of the procedure.
Who cannot join
- 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.
About this study
Official title: Remote Manipulation of a Capsule Endoscope in the Esophagus and Stomach of a Human Volunteer Using an External Hand-held Magnet
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Healthy Volunteer, Given Capsule Manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Given Imaging
- Investigators
- Richard I Rothstein, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044797
- Sponsor's protocol ID
- Given Imaging DHMC
- Acronym
- Remote capsule
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Manipulation of a Capsule Endoscope in the Esophagus and Stomach of a Human Volunteer Using an External Hand-held Magnet
- ClinicalTrials.gov ID
- NCT01044797
- Acronym / sponsor ID
- Remote capsule / Given Imaging DHMC
- Conditions
- Healthy
- Keywords
- Healthy Volunteer, Given Capsule Manipulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Given Imaging
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Jan 2010 (estimated)
- 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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One Human Volunteer, Healthy
Key inclusion criteria (1 listed)
- Asymptomatic adult volunteer with previously determined normal esophagus and stomach who understands the risks of the procedure.
Key exclusion criteria (7 listed)
- Known strictures in the intestine,
- Crohn's disease,
- Swallowing difficulty,
- Age less than 21,
- Age over 75 or have a pacemaker,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
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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. This study is not recruiting at the moment.
Richard I Rothstein, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Dartmouth-Hitchcock Medical Center.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 8 Jan 2010.