Colonic PolypsNCT05737017
The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)
A study testing ClearCoajet in people with Colonic Polyps, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- ClearCoajet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2022to 31 Dec 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm
Who cannot join
- Pedunculated polyp
- Patients with coagulopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeouido St. Mary's Hospital
Seoul, 07345
Han Hee Lee, MD, 82-2-2258-2083, hanyee99@hanmail.net
About this study
Official title: A Randomized Active-controlled Clinical Trial to Investigate the Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet) During Endoscopic Resection for Colorectal Tumors
The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.
- Conditions
- Colonic Polyps
- Being tested
- ClearCoajet
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearCoajetDevice
The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure.
| Study group | Role | What they receive |
|---|---|---|
| The ClearCoajet group | Experimental | During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding. Receives: Device: ClearCoajet |
| The control group | Active comparator | During the endoscopic resection procedures, the conventional injector will be used for injection. Receives: Device: ClearCoajet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis of intraprocedural bleeding
Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions
Measured: during endoscopic resection for colorectal lesions
Secondary outcomes (2)
Delayed bleeding rate
Delayed bleeding rate within 4 weeks after endoscopic resection
Measured: within 4 weeks after endoscopic resection
Complication rate
Complication rate
Measured: within 4 weeks after endoscopic resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Nov 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Hee Lee, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737017
- Sponsor's protocol ID
- Coajet_LGI
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nam Y, Lee HH, Lee J, Seo SI, Kim SH, Jung Y, Cheung DY, Lee BI, Kim TO, Kim JI, Lee HS. Hemostatic Efficacy and Safety of the Hybrid Injector ClearCoajet in Endoscopic Mucosal Resection of Large Colorectal Polyps: A Multicenter Randomized Trial. Dig Dis Sci. 2026 Aug 18. doi: 10.1007/s10620-026-10163-w. Online ahead of print.
PubMed 42611155
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Active-controlled Clinical Trial to Investigate the Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet) During Endoscopic Resection for Colorectal Tumors
- ClinicalTrials.gov ID
- NCT05737017
- Acronym / sponsor ID
- Coajet_LGI
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Feb 2023 (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.
The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ClearCoajet group | Experimental | Device: ClearCoajetDuring the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding. |
| The control group | Active comparator | Device: ClearCoajetDuring the endoscopic resection procedures, the conventional injector will be used for injection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm
Key exclusion criteria (2 listed)
- Pedunculated polyp
- Patients with 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 |
|---|---|---|
| ClearCoajetThe ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. | Device | The ClearCoajet group, The control group |
Primary outcome
Hemostasis of intraprocedural bleeding
Time frame: during endoscopic resection for colorectal lesions
Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions
2 secondary outcomes
Delayed bleeding rate
Time frame: within 4 weeks after endoscopic resection
Complication rate
Time frame: within 4 weeks after endoscopic resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 42611155Nam Y, Lee HH, Lee J, Seo SI, Kim SH, Jung Y, Cheung DY, Lee BI, Kim TO, Kim JI, Lee HS. Hemostatic Efficacy and Safety of the Hybrid Injector ClearCoajet in Endoscopic Mucosal Resection of Large Colorectal Polyps: A Multicenter Randomized Trial. Dig Dis Sci. 2026 Aug 18. doi: 10.1007/s10620-026-10163-w. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearCoajet in people with Colonic Polyps, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis of intraprocedural bleeding (time frame: during endoscopic resection for colorectal lesions). 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 NCT05737017, which also lists 1 linked publication.
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 24 Feb 2023.