Colonic PolypNCT03901651
Combined Forward and Retroflexion Withdrawal in the Detection of Polyps and Adenoma During Colonoscopy
A study testing Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique and Colonoscopy with standard colonoscope and forward withdrawal technique in people with Colonic Polyp and Colonic Neoplasms, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
Colonoscopy is the standard of care for the detection of colorectal polyps and adenoma, and colorectal cancer detection. Despite a meticulous evaluation of the colonic mucosa during colonoscopy, a substantial number of colorectal polyps might be missed and colorectal cancer might not be prevented. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colonic Polyp, Colonic Neoplasms, Colonic Adenoma
- What is being tested?
- Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique and Colonoscopy with standard colonoscope and forward withdrawal technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteEcuador
- Study dates
- 2 Jan 2019to 1 Jan 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients capable of providing written consent
- Colonoscopy indicated for colorectal cancer screening or surveillance
- Patients submitted for polypectomy
- Colonoscopy indicated for diagnostic purposes: anemia, abdominal pain, constipation, alteration of bowel habits.
Who cannot join
- Patients under 45 years and over 80 years of age.
- Pregnancy and/or nursing.
- Patients with past-medical history of cardiac, renal, hepatic or severe metabolic diseases
- Unable to tolerate sedation
- Severe uncontrolled coagulopathy
- Past surgical history of colonic resection, ileostomy or colostomy.
Show all 12Show fewer
- Previous abdominal or pelvic radiation therapy.
- Patients with inflammatory bowel disease, polyposis syndrome or acute diverticulitis.
- Patients with high suspicion of colonic obstruction or history of prior obstruction.
- Patients with gastrointestinal bleeding.
- Inadequate bowel preparation. The bowel preparation will be evaluated using the Boston Bowel Preparation Scale. Patients with < 2 points in at least one of the three segments of the colon will be excluded.
- Patients who after the beginning of the colonoscopy have to be suspended due to the inability to reach into the cecum because of unfavorable anatomy or impassable tumors/stenosis.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505
About this study
Colonoscopy is the standard of care for the detection of colorectal polyps and adenoma, and colorectal cancer detection. Despite a meticulous evaluation of the colonic mucosa during colonoscopy, a substantial number of colorectal polyps might be missed and colorectal cancer might not be prevented.
Previous studies described a 12-28% of miss-rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with a higher miss rate noted for smaller polyps. The lesion missing rate depends on several factors, such as the location on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, an inadequate bowel preparation and inadequate endoscopy technique, a time-limited colonoscope withdrawal.
Read more
If the standard 140º angle of view colonoscope is used approximately 13% of the colonic surface is unevaluated. The incorporation of colonoscopes with a 170-degree wide angled could improve adenoma detection rate.
The introduction of high definition (HD) colonoscopes and visual image enhancement technologies, such as narrow band imaging (NBI, Olympus America, Center Valley, PA), I-SCAN™ (Pentax Medical, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization; however, several studies have failed to prove an increase in the adenoma detection rates.
The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced through the accessory channel of a standard colonoscope. It allows retrograde viewing behind colonic folds and flexures simultaneously with the forward view of the colon. Although it shows an increase in the adenoma detection rate by 11%-25%, it has many disadvantages. First, it requires a separate processor and the device is disposable, increasing the cost of the procedure. Second, it occupies the working channel of the colonoscope, limiting the ability to suction. Third, if a polyp is detected, the viewing device has to be removed in order to perform the polypectomy. Fourth, the optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscopy and from the retroscope device.
Read the detailed description
The Retroview™ (Pentax Medical, HOYA Co.) colonoscope has a short turning radius at the colonoscope tip, that allows a retroflexed view of the colon during withdrawal. This might allow the detection of polyps hidden behind flexures, folds, and valves, from the cecum to the rectum.
This device offers many advantages, such as the ability to provide a high definition view of the proximal aspects of colonic folds, flexures, and valves with no additional equipment or device costs. The image quality is high definition and the colonoscope also incorporates the I-SCAN technology. The suction/work channel of the colonoscope is available for therapeutic procedures. Polypectomy can be performed with the colonoscope during retroflexion, without losing view of the polyp. The only disadvantages are the higher consumed withdrawal time because the additional retroflexed withdrawal to the standard withdrawal and that a small portion of the colon is obscured by the shaft of the colonoscope in retroflexion that may be the reason why combined standard withdrawal with retroflexed withdrawal has proved to be better than retroflexed withdrawal alone.
The aim of this study is to determinate the polyp and adenoma detection rate via performing a colonoscopy using a conventional scope with standard withdrawal (forward view) and a combined forward and retroflexed withdrawal technique using the RetroView™ colonoscope.
Lesion's dimensions and characteristics will be recorded to determine a difference between both techniques.
MATERIALS AND METHODS Setting: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Omni Hospital Academic Tertiary Center. We will include patients from January 2019 to November 2019. The study protocol and consent form has been approved by the Institutional Review Board of our institution and will be conducted according to the Declaration of Helsinki. Patients will provide written informed consent.
Intervention: endoscopic technique. Participants will be submitted to two colonoscopies on the same day. First, a standard colonoscopy will be performed using a conventional HD colonoscope with I-Scan (EC 3490LK, PENTAX, Montvale, NJ) that has a 13.2 mm tube diameter and a total length of 2023 mm). Then a second procedure, combining the standard forward view and retroflexed withdrawal will be performed using the Retroview™ colonoscope (EC34-i10TL, Pentax Medical, Montvale, NJ), that has an 11.6 mm tube diameter and 2023 mm length.
The endoscopy images will be seen on a 27-inch, flat panel, HD LCD monitor (Radiance™ ultra-SC-WU27-G1520 model). All participants will have the same colonic preparation with 4 liters of polyethylene glycol (PEG) the day before and bowel preparation will be evaluated using the Boston Bowel Preparation Scale.
Two endoscopists with proficiency in retroflexed withdrawal will perform the colonoscopies. Colonoscopies will be performed in a tandem, random manner. First one endoscopist will perform the conventional colonoscopy using standard withdrawal technique with standard colonoscopes and then the second endoscopist blinded to the first colonoscopy results will perform the second colonoscopy with the Retroview scope and combination withdrawal (retroflexed with standard withdrawal). The operator assigned to each colonoscopy will be chosen randomly. A minimum withdrawal time of 10 minutes will be required for each procedure. After the examination, endoscopist will fill a questionnaire describing each polyp and adenoma found, including the size and location. The withdrawal time spent in each procedure will be measured.
Statistical analysis: Baseline characteristics will be analyzed using Chi-square o Fisher Test for categorical variable and Mann-Whitney Test for continuous variables. If there is more than one polyp in one patient it will be considered individually for statistical purposes. A P value of less than 0.05 will be considered statistically significant. All the statistical analysis will be performed using R.
Limitations: The protocol will be performed in a single-center by six endoscopists. A lack of a control group because the intention is to compare two endoscopic techniques in the same setting.
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Adenoma
- Being tested
- Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique, Colonoscopy with standard colonoscope and forward withdrawal technique
- Keywords
- colonic polyps
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with Retroview scope combing forward and retroflexed withdrawal techniqueDiagnostic test
Colonoscopy using a combined forward and retroflexed evaluation of the colonic mucosa. using the Retroview™ scope. The operator will be blind to the standard colonoscopy findings.
The operator will record the polyps and adenoma encountered, describing the size and location.
Colonoscopy with standard colonoscope and forward withdrawal techniqueDiagnostic test
A standard colonoscopy with forwarding viewing withdrawal technique. An HD colonoscope with I-scan technology will be used by one expert endoscopist.
Each polyp and adenoma will be recorded, including the size and location.
| Study group | Role | What they receive |
|---|---|---|
| Standard colonoscopy | Active comparator | Patients submitted for screening, surveillance or diagnostic colonoscopy. A standard colonoscopy with forwarding viewing withdrawal technique. An HD colonoscope with I-scan technology will be used by one expert endoscopist.
Each polyp and adenoma will be recorded, including the size and location. Polyps will be removed before the second procedure. Receives: Diagnostic Test: Colonoscopy with standard colonoscope and forward withdrawal technique |
| Retroview colonoscopy | Experimental | The same group of patients. A second colonoscopy using a combined forward and retroflexed evaluation of the colonic mucosa. using the Retroview™ scope. The operator will be blind to the first colonoscopy findings.
The operator will record the polyps and adenoma encountered, describing the size and location. Receives: Diagnostic Test: Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection rate with standard colonoscope and the Retroview colonoscope
Polyps found during standard colonoscopy/total of polyps found x 100; polyps found with the Retroview scope/total of polyps found x100. The total of polyps found will be defined by the combination of both methods
Measured: 23 months
Adenoma detection rate with standard colonoscope and retroview colonoscope.
Adenomas found during standard colonoscopy/total of adenomas found x 100; adenomas found with the Retroview scope/total of adenomas found x100. The total of adenomas found will be defined by the combination of both methods
Measured: 23 months
Secondary outcomes (3)
Lesion miss rate with the standard colonoscope and Retroview scope
Lesion miss rate: missed lesions/ total of lesions (polyps and adenomas) x100
Measured: 23 months
Number of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview colonoscope.
The number of lesions will be described in each patient from both procedures.
Measured: 23 months
Size of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview colonoscope.
The size of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview colonoscope. The size will be measured using a standard biopsy forceps as a comparison method.
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start2 Jan 2019
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients submitted for screening, surveillance or diagnostic colonoscopy. First, a colonoscopy using a HD standard colonoscope using a forward viewing withdrawal technique. Then, a second colonoscopy using the Retroview colonoscope combining forward and retroflexed evaluation of the colon will be performed in the same patient.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Robles-Medranda, MC, Principal investigator, Instituto Ecuatoriano de Enfermedades Digestivas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901651
- Sponsor's protocol ID
- RV03-2019
- Status last verified
- Jun 2021
- First submitted
- 25 Mar 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Forward and Retroflexion Withdrawal in the Detection of Polyps and Adenoma During Colonoscopy
- ClinicalTrials.gov ID
- NCT03901651
- Acronym / sponsor ID
- RV03-2019
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Adenoma
- Keywords
- colonic polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 3 Apr 2019 (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.
Colonoscopy is the standard of care for the detection of colorectal polyps and adenoma, and colorectal cancer detection. Despite a meticulous evaluation of the colonic mucosa during colonoscopy, a substantial number of colorectal polyps might be missed and colorectal cancer might not be prevented.
Previous studies described a 12-28% of miss-rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with a higher miss rate noted for smaller polyps. The lesion missing rate depends on several factors, such as the location on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, an inadequate bowel preparation and inadequate endoscopy technique, a time-limited colonoscope withdrawal.
If the standard 140º angle of view colonoscope is used approximately 13% of the colonic surface is unevaluated. The incorporation of colonoscopes with a 170-degree wide angled could improve adenoma detection rate.
The introduction of high definition (HD) colonoscopes and visual image enhancement technologies, such as narrow band imaging (NBI, Olympus America, Center Valley, PA), I-SCAN™ (Pentax Medical, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization; however, several studies have failed to prove an increase in the adenoma detection rates.
The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced through the accessory channel of a standard colonoscope. It allows retrograde viewing behind colonic folds and flexures simultaneously with the forward view of the colon. Although it shows an increase in the adenoma detection rate by 11%-25%, it has many disadvantages. First, it requires a separate processor and the device is disposable, increasing the cost of the procedure. Second, it occupies the working channel of the colonoscope, limiting the ability to suction. Third, if a polyp is detected, the viewing device has to be removed in order to perform the polypectomy. Fourth, the optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscopy and from the retroscope device.
Detailed description
The Retroview™ (Pentax Medical, HOYA Co.) colonoscope has a short turning radius at the colonoscope tip, that allows a retroflexed view of the colon during withdrawal. This might allow the detection of polyps hidden behind flexures, folds, and valves, from the cecum to the rectum.
This device offers many advantages, such as the ability to provide a high definition view of the proximal aspects of colonic folds, flexures, and valves with no additional equipment or device costs. The image quality is high definition and the colonoscope also incorporates the I-SCAN technology. The suction/work channel of the colonoscope is available for therapeutic procedures. Polypectomy can be performed with the colonoscope during retroflexion, without losing view of the polyp. The only disadvantages are the higher consumed withdrawal time because the additional retroflexed withdrawal to the standard withdrawal and that a small portion of the colon is obscured by the shaft of the colonoscope in retroflexion that may be the reason why combined standard withdrawal with retroflexed withdrawal has proved to be better than retroflexed withdrawal alone.
The aim of this study is to determinate the polyp and adenoma detection rate via performing a colonoscopy using a conventional scope with standard withdrawal (forward view) and a combined forward and retroflexed withdrawal technique using the RetroView™ colonoscope.
Lesion's dimensions and characteristics will be recorded to determine a difference between both techniques.
MATERIALS AND METHODS Setting: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Omni Hospital Academic Tertiary Center. We will include patients from January 2019 to November 2019. The study protocol and consent form has been approved by the Institutional Review Board of our institution and will be conducted according to the Declaration of Helsinki. Patients will provide written informed consent.
Intervention: endoscopic technique. Participants will be submitted to two colonoscopies on the same day. First, a standard colonoscopy will be performed using a conventional HD colonoscope with I-Scan (EC 3490LK, PENTAX, Montvale, NJ) that has a 13.2 mm tube diameter and a total length of 2023 mm). Then a second procedure, combining the standard forward view and retroflexed withdrawal will be performed using the Retroview™ colonoscope (EC34-i10TL, Pentax Medical, Montvale, NJ), that has an 11.6 mm tube diameter and 2023 mm length.
The endoscopy images will be seen on a 27-inch, flat panel, HD LCD monitor (Radiance™ ultra-SC-WU27-G1520 model). All participants will have the same colonic preparation with 4 liters of polyethylene glycol (PEG) the day before and bowel preparation will be evaluated using the Boston Bowel Preparation Scale.
Two endoscopists with proficiency in retroflexed withdrawal will perform the colonoscopies. Colonoscopies will be performed in a tandem, random manner. First one endoscopist will perform the conventional colonoscopy using standard withdrawal technique with standard colonoscopes and then the second endoscopist blinded to the first colonoscopy results will perform the second colonoscopy with the Retroview scope and combination withdrawal (retroflexed with standard withdrawal). The operator assigned to each colonoscopy will be chosen randomly. A minimum withdrawal time of 10 minutes will be required for each procedure. After the examination, endoscopist will fill a questionnaire describing each polyp and adenoma found, including the size and location. The withdrawal time spent in each procedure will be measured.
Statistical analysis: Baseline characteristics will be analyzed using Chi-square o Fisher Test for categorical variable and Mann-Whitney Test for continuous variables. If there is more than one polyp in one patient it will be considered individually for statistical purposes. A P value of less than 0.05 will be considered statistically significant. All the statistical analysis will be performed using R.
Limitations: The protocol will be performed in a single-center by six endoscopists. A lack of a control group because the intention is to compare two endoscopic techniques in the same setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients submitted for screening, surveillance or diagnostic colonoscopy. First, a colonoscopy using a HD standard colonoscope using a forward viewing withdrawal technique. Then, a second colonoscopy using the Retroview colonoscope combining forward and retroflexed evaluation of the colon will be performed in the same patient.
| Arm | Type | Receives |
|---|---|---|
| Standard colonoscopy | Active comparator | Diagnostic Test: Colonoscopy with standard colonoscope and forward withdrawal techniquePatients submitted for screening, surveillance or diagnostic colonoscopy. A standard colonoscopy with forwarding viewing withdrawal technique. An HD colonoscope with I-scan technology will be used by one expert endoscopist. Each polyp and adenoma will be recorded, including the size and location. Polyps will be removed before the second procedure. |
| Retroview colonoscopy | Experimental | Diagnostic Test: Colonoscopy with Retroview scope combing forward and retroflexed withdrawal techniqueThe same group of patients. A second colonoscopy using a combined forward and retroflexed evaluation of the colonic mucosa. using the Retroview™ scope. The operator will be blind to the first colonoscopy findings. The operator will record the polyps and adenoma encountered, describing the size and location. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients capable of providing written consent
- Colonoscopy indicated for colorectal cancer screening or surveillance
- Patients submitted for polypectomy
- Colonoscopy indicated for diagnostic purposes: anemia, abdominal pain, constipation, alteration of bowel habits.
Key exclusion criteria (12 listed)
- Patients under 45 years and over 80 years of age.
- Pregnancy and/or nursing.
- Patients with past-medical history of cardiac, renal, hepatic or severe metabolic diseases
- Unable to tolerate sedation
- Severe uncontrolled coagulopathy
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 |
|---|---|---|
| Colonoscopy with Retroview scope combing forward and retroflexed withdrawal techniqueColonoscopy using a combined forward and retroflexed evaluation of the colonic mucosa. using the Retroview™ scope. The operator will be blind to the standard colonoscopy findings. The operator will record the polyps and adenoma encountered, describing the size and location. | Diagnostic test | Retroview colonoscopy |
| Colonoscopy with standard colonoscope and forward withdrawal techniqueA standard colonoscopy with forwarding viewing withdrawal technique. An HD colonoscope with I-scan technology will be used by one expert endoscopist. Each polyp and adenoma will be recorded, including the size and location. | Diagnostic test | Standard colonoscopy |
Primary outcome
Polyp detection rate with standard colonoscope and the Retroview colonoscope
Time frame: 23 months
Polyps found during standard colonoscopy/total of polyps found x 100; polyps found with the Retroview scope/total of polyps found x100. The total of polyps found will be defined by the combination of both methods
Adenoma detection rate with standard colonoscope and retroview colonoscope.
Time frame: 23 months
Adenomas found during standard colonoscopy/total of adenomas found x 100; adenomas found with the Retroview scope/total of adenomas found x100. The total of adenomas found will be defined by the combination of both methods
3 secondary outcomes
Lesion miss rate with the standard colonoscope and Retroview scope
Time frame: 23 months
Number of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview colonoscope.
Time frame: 23 months
Size of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview colonoscope.
Time frame: 23 months
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 2 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Carlos Robles-Medranda, MC principal investigator
Instituto Ecuatoriano de Enfermedades Digestivas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique and Colonoscopy with standard colonoscope and forward withdrawal technique in people with Colonic Polyp and Colonic Neoplasms, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 4 inclusion and 12 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. 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?
Polyp detection rate with standard colonoscope and the Retroview colonoscope (time frame: 23 months). The study lists 2 primary outcomes in all. 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 2 Jun 2021.