ColonoscopyNCT07076966
Comparison of Adenoma Detection Rate in 3D vs. 2D Surveillance Colonoscopy
A study testing 3D device in people with Colonoscopy and Adenoma Detection Rate, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colonoscopy, Adenoma Detection Rate, Three Dimensional
- What is being tested?
- 3D device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Jan 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are 40 years of older
- Subjects who receive colonoscopy and polypectomy more the 1 year
- Subjects who need surveillance colonoscopy
Who cannot join
- Contraindication for colonoscopy
- Subjects with familiar or hereditary polyposis
- Subjects with history of colectomy
- Inadequate bowel cleansing level
- Subjects with inflammatory bowel disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
National Taiwan University Hospital, Hsinchu Branch
Hsinchu
Hsuan-Ho Lin, MD, MSc, 886-2-23123456, tostart21@gmail.com
- Recruiting
National Taiwan University Cancer Center
Taipei, 100
Hao-Che Chang, MD, 886-2-23123456, andrewhcchang@gmail.com
- Recruiting
National Taiwan University Hospital
Taipei, 100
Li-Chun Chang, MD. PhD., 886-9-72-651-258, lichunchang@ntu.edu.tw
Li-Chun Chang, MD. PhD.
About this study
Official title: Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: A Multi-center, Randomized Controlled Trial
There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of colorectal cancer. Recent studies have further demonstrated that improving ADR can reduce future mortality from colorectal cancer. Notably, non-polypoid lesions (such as flat or depressed lesions) are more likely to be missed during traditional colonoscopy, making these lesions a leading cause of post-colonoscopy interval colorectal cancer.
In a prospective trial conducted by our team comparing the ADR of 3D colonoscopy with standard 2D colonoscopy, we found that 3D colonoscopy significantly improved overall ADR and the detection rate of non-polypoid adenomas.
Read more
According to current international guidelines, after an index colonoscopy, patients are recommended to undergo surveillance colonoscopy 1 to 10 years later, depending on their findings at index colonoscopy. Since these patients represent the majority in clinical practice, increasing the ADR during surveillance colonoscopy not only allows for more precise recommendations for the timing of the next colonoscopy but also effectively reduces the risk of post-colonoscopy colorectal cancer (PCCRC).
Therefore, this multicenter, prospective, randomized trial aims to compare the clinical performance of 3D colonoscopy and standard 2D colonoscopy in the context of surveillance colonoscopy.
- Being tested
- 3D device
- Keywords
- Colonoscopy, adenoma detection rate, 3D, surveillance colonoscopy
- Medical subject headings
- Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D deviceDevice
Use 3D machine to generate the 3D image
| Study group | Role | What they receive |
|---|---|---|
| 3D colonoscopy | Experimental | Not described Receives: Device: 3D device |
| 2D colonoscopy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: 30 minutes
Secondary outcomes (9)
Flat-ADR
detection rate of flat adenoma
Measured: 30 minutes
Proximal ADR
detection rate of adenoma at proximal colon
Measured: 30 minutes
Distal ADR
detection rate of adenoma at distal colon
Measured: 30 minutes
SSLDR
detection rate of sessile serrated lesion
Measured: 30 minutes
AADR
detection rate of advanced adenoma
Measured: 30 minutes
Detection of of adenoma with various size
Measured: 30 minutes
Polyp detection rate
Measured: 30 minutes
Adenoma number per colonoscopy,
Measured: 30 minutes
Polyp number per colonoscopy
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3D colonoscopy versus standard 2D colonoscopy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Statistical Center, NTUHCTC, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076966
- Sponsor's protocol ID
- 202311019DIPC
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07076966
- Acronym / sponsor ID
- 202311019DIPC
- Keywords
- Colonoscopy, adenoma detection rate, 3D, surveillance colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Jul 2025 (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.
There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of colorectal cancer. Recent studies have further demonstrated that improving ADR can reduce future mortality from colorectal cancer. Notably, non-polypoid lesions (such as flat or depressed lesions) are more likely to be missed during traditional colonoscopy, making these lesions a leading cause of post-colonoscopy interval colorectal cancer.
In a prospective trial conducted by our team comparing the ADR of 3D colonoscopy with standard 2D colonoscopy, we found that 3D colonoscopy significantly improved overall ADR and the detection rate of non-polypoid adenomas.
According to current international guidelines, after an index colonoscopy, patients are recommended to undergo surveillance colonoscopy 1 to 10 years later, depending on their findings at index colonoscopy. Since these patients represent the majority in clinical practice, increasing the ADR during surveillance colonoscopy not only allows for more precise recommendations for the timing of the next colonoscopy but also effectively reduces the risk of post-colonoscopy colorectal cancer (PCCRC).
Therefore, this multicenter, prospective, randomized trial aims to compare the clinical performance of 3D colonoscopy and standard 2D colonoscopy in the context of surveillance colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 3D colonoscopy versus standard 2D colonoscopy
| Arm | Type | Receives |
|---|---|---|
| 3D colonoscopy | Experimental | Device: 3D device |
| 2D colonoscopy | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are 40 years of older
- Subjects who receive colonoscopy and polypectomy more the 1 year
- Subjects who need surveillance colonoscopy
Key exclusion criteria (5 listed)
- Contraindication for colonoscopy
- Subjects with familiar or hereditary polyposis
- Subjects with history of colectomy
- Inadequate bowel cleansing level
- Subjects with inflammatory bowel disease
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 |
|---|---|---|
| 3D deviceUse 3D machine to generate the 3D image | Device | 3D colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: 30 minutes
9 secondary outcomes
Flat-ADR
Time frame: 30 minutes
Proximal ADR
Time frame: 30 minutes
Distal ADR
Time frame: 30 minutes
SSLDR
Time frame: 30 minutes
AADR
Time frame: 30 minutes
Detection of of adenoma with various size
Time frame: 30 minutes
Polyp detection rate
Time frame: 30 minutes
Adenoma number per colonoscopy,
Time frame: 30 minutes
Polyp number per colonoscopy
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D device in people with Colonoscopy and Adenoma Detection Rate, run by National Taiwan University Hospital at 3 sites in Taiwan.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Chun Chang, MD. PhD. (886-9-72-651-258, lichunchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 30 minutes). 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 29 Sep 2026.