Sessile Serrated LesionNCT07601230
Polyp Pretreatment Device for SSL Diagnosis
A study testing Polyp Pretreatment Device in people with Sessile Serrated Lesion, run by Changhai Hospital.
Trial summary
Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sessile Serrated Lesion
- What is being tested?
- Polyp Pretreatment Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,156 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 1 May 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple).
- Sessile/flat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens.
- Signed informed consent.
Who cannot join
- Refusal or lack of informed consent.
- Polyp size ≥25 mm or fragmented resection.
- Severe specimen damage/cautery artifact or time from resection to fixation >30 min.
- Suspected/confirmed CRC, IBD, or polyposis syndromes.
- Anticoagulants (aspirin/warfarin) within 7 days or coagulation disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps
Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.
- Conditions
- Sessile Serrated Lesion
- Being tested
- Polyp Pretreatment Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyp Pretreatment DeviceDevice
This novel polyp pretreatment device is a single-use, non-invasive laboratory tool designed to standardize the orientation and fixation of resected colorectal polyp specimens. The device consists of a flat, rigid base with a transparent, non-adherent cover, and is engineered to maintain the mucosal surface of the polyp specimen flat and fully extended.
| Study group | Role | What they receive |
|---|---|---|
| Polyp Pretreatment Device | Experimental | Not described Receives: Device: Polyp Pretreatment Device |
| Standard Processing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSL Diagnostic Rate (%)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sessile Serrated LesionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heilongjiang Provicial Hospital, Ankang Central Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Nanchang University, Ya'an People's Hospital, The Second Hospital of Hebei Medical University, Chongqing General Hospital, Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Shanxi Provincial People's Hospital, Shanghai Sixth Hospital, People's Hospital of Leshan, Sichuan Province, The Third People's Hospital of Chengdu, The Third People's Hospital of Jingdezhen, Ningbo Hospital of Integrated Traditional Chinese and Western Medicine, Shandong Provincial Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601230
- Sponsor's protocol ID
- CHSDR202601
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tran TH, Nguyen VH, Vo DT. How to "pick up" colorectal serrated lesions and polyps in daily histopathology practice: From terminologies to diagnostic pitfalls. World J Clin Oncol. 2024 Sep 24;15(9):1157-1167. doi: 10.5306/wjco.v15.i9.1157.
PubMed 39351466Kolb JM, Morales SJ, Rouse NA, Desai J, Friedman K, Makris L, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Rouse RV, Aisenberg J. Does Better Specimen Orientation and a Simplified Grading System Promote More Reliable Histologic Interpretation of Serrated Colon Polyps in the Community Practice Setting? Results of a Nationwide Study. J Clin Gastroenterol. 2016 Mar;50(3):233-8. doi: 10.1097/MCG.0000000000000413.
PubMed 26501882Morales SJ, Bodian CA, Kornacki S, Rouse RV, Petras R, Rouse NA, Cohen LB, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Aisenberg J. A simple tissue-handling technique performed in the endoscopy suite improves histologic section quality and diagnostic accuracy for serrated polyps. Endoscopy. 2013 Nov;45(11):897-905. doi: 10.1055/s-0033-1344435. Epub 2013 Oct 28.
PubMed 24165815
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps
- ClinicalTrials.gov ID
- NCT07601230
- Acronym / sponsor ID
- CHSDR202601
- Conditions
- Sessile Serrated Lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,156 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Heilongjiang Provicial Hospital, Ankang Central Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Nanchang University, Ya'an People's Hospital, The Second Hospital of Hebei Medical University, Chongqing General Hospital, Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Shanxi Provincial People's Hospital, Shanghai Sixth Hospital, People's Hospital of Leshan, Sichuan Province, The Third People's Hospital of Chengdu, The Third People's Hospital of Jingdezhen, Ningbo Hospital of Integrated Traditional Chinese and Western Medicine, Shandong Provincial Hospital
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 22 May 2026 (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.
Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyp Pretreatment Device | Experimental | Device: Polyp Pretreatment Device |
| Standard Processing | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple).
- Sessile/flat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Refusal or lack of informed consent.
- Polyp size ≥25 mm or fragmented resection.
- Severe specimen damage/cautery artifact or time from resection to fixation >30 min.
- Suspected/confirmed CRC, IBD, or polyposis syndromes.
- Anticoagulants (aspirin/warfarin) within 7 days or coagulation disorders.
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 |
|---|---|---|
| Polyp Pretreatment DeviceThis novel polyp pretreatment device is a single-use, non-invasive laboratory tool designed to standardize the orientation and fixation of resected colorectal polyp specimens. The device consists of a flat, rigid base with a transparent, non-adherent cover, and is engineered to maintain the mucosal surface of the polyp specimen flat and fully extended. | Device | Polyp Pretreatment Device |
Primary outcome
SSL Diagnostic Rate (%)
Time frame: 7 days
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 22 May 2026.
- Background: PubMed 39351466Tran TH, Nguyen VH, Vo DT. How to "pick up" colorectal serrated lesions and polyps in daily histopathology practice: From terminologies to diagnostic pitfalls. World J Clin Oncol. 2024 Sep 24;15(9):1157-1167. doi: 10.5306/wjco.v15.i9.1157.
- Background: PubMed 26501882Kolb JM, Morales SJ, Rouse NA, Desai J, Friedman K, Makris L, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Rouse RV, Aisenberg J. Does Better Specimen Orientation and a Simplified Grading System Promote More Reliable Histologic Interpretation of Serrated Colon Polyps in the Community Practice Setting? Results of a Nationwide Study. J Clin Gastroenterol. 2016 Mar;50(3):233-8. doi: 10.1097/MCG.0000000000000413.
- Background: PubMed 24165815Morales SJ, Bodian CA, Kornacki S, Rouse RV, Petras R, Rouse NA, Cohen LB, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Aisenberg J. A simple tissue-handling technique performed in the endoscopy suite improves histologic section quality and diagnostic accuracy for serrated polyps. Endoscopy. 2013 Nov;45(11):897-905. doi: 10.1055/s-0033-1344435. Epub 2013 Oct 28.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Polyp Pretreatment Device in people with Sessile Serrated Lesion, run by Changhai Hospital.
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: opening soon, as of the sponsor's last update on 22 May 2026. 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?
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 Zhaoshen Li (86-021-31161365, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSL Diagnostic Rate (%) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07601230, which also lists 3 linked publications.
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 22 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.