ColonoscopyNCT04246632
CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
A study testing CapsoCam Colon Capsule Endoscopy in people with Colonoscopy, run by Capso Vision, Inc. at 3 sites in United States.
Trial summary
This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- CapsoCam Colon Capsule Endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jan 2020to 15 Mar 2021
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 50 and 75 years old
- Subject meets at least one of the following criteria for increased risk for polyps:
- Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test
- Older than 55 years of age, without prior history of colonoscopy
- Has had a positive colonoscopy ≥ 5 years prior to screening visit
- And/or having at least two of the following risk factors:
Show all 14Show fewer
- Current smoker
- BMI of ≥30
- Family history (blood relative) of colorectal cancer
- Sedentary lifestyle
- Low fiber/ high fat diet
- No contraindication for capsule endoscopy or colonoscopy
- Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
- Choose to participate and must have signed the IRB-approved informed-consent document and agreed to release colonoscopy images and results report to Sponsor
Who cannot join
- History of negative colonoscopy within the last 10 years
- History of incomplete colonoscopy
- Impaired cardiac function assessed as greater than NYHA Class II
- History of small- or large-bowel obstructive condition
- Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis
- Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the patient at greater risk for capsule endoscope retention
Show all 22Show fewer
- Unable to follow or tolerate fasting, bowel preparation, and other study procedures
- Known allergy to ingredients used in bowel preparation and boosters
- Daily and/or regular use of narcotics
- Known or suspected AIDS
- Uncompensated cirrhosis
- Prior abdominal radiation therapy
- Diagnosis of anorexia or bulimia
- History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion
- Known or suspected megacolon
- Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
- Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
- Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening.
- Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study
- Are currently enrolled in, or participated in within the last 30 days, another clinical study
- Chronic constipation as defined by <3 bowel movements per week for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain r regular bowel movements for at least 3 months prior to Screening
- History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Silicon Valley Research Institute, Inc.
San Jose, California, 95116
CapsoVision Research Clinic
Saratoga, California, 95070
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
About this study
Official title: Prospective, Open Label, Pilot Study of the CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- CapsoCam Colon Capsule Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsoCam Colon Capsule EndoscopyDevice
CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | Single arm study, all subjects receive device Receives: Device: CapsoCam Colon Capsule Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessments
Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure.
Measured: Day 1
Secondary outcomes (1)
Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs)
All adverse events including SAEs/UADEs will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be reported. A serious adverse event is one that meets the definition outlined in Section 8 of this protocol.
Measured: Day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start25 Jan 2020
- Primary completion25 Feb 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-Center; Prospective, Open Label, Non-Significant Risk, Pilot Study
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capso Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246632
- Sponsor's protocol ID
- CLN-CVI-5248
- Status last verified
- Aug 2021
- First submitted
- 24 Jan 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All IPD will be kept confidential. Safety events/concerns will be shared will all sites without exposing PHI.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Pilot Study of the CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
- ClinicalTrials.gov ID
- NCT04246632
- Acronym / sponsor ID
- CLN-CVI-5248
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Capso Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- 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.
This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-Center; Prospective, Open Label, Non-Significant Risk, Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Device: CapsoCam Colon Capsule EndoscopySingle arm study, all subjects receive device |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Between the ages of 50 and 75 years old
- Subject meets at least one of the following criteria for increased risk for polyps:
- No contraindication for capsule endoscopy or colonoscopy
- Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
- Choose to participate and must have signed the IRB-approved informed-consent document and agreed to release colonoscopy images and results report to Sponsor
Key exclusion criteria (22 listed)
- History of negative colonoscopy within the last 10 years
- History of incomplete colonoscopy
- Impaired cardiac function assessed as greater than NYHA Class II
- History of small- or large-bowel obstructive condition
- Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsoCam Colon Capsule EndoscopyCapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults. | Device | Open label |
Primary outcome
Efficacy Assessments
Time frame: Day 1
Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure.
1 secondary outcome
Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs)
Time frame: Day 1-3
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 6 Aug 2021.
- Individual participant dataSharing planned: No. All IPD will be kept confidential. Safety events/concerns will be shared will all sites without exposing PHI.
Related trials for Colonoscopy
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
Enrolling by invitation
The Effect of Virtual Reality Application on Pain, Anxiety, and Embarrassment During Colonoscopy
Colonoscopy
Recruiting
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Adenoma Detection Rate, Colonoscopy
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CapsoCam Colon Capsule Endoscopy in people with Colonoscopy, run by Capso Vision, Inc. at 3 sites in United States.
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 14 inclusion and 22 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 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Efficacy Assessments (time frame: Day 1). It is what the study was designed to measure, not a finding.
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 6 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.