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
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