Peptic Ulcer HemorrhageNCT04536428
ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding
A study testing Endoscopic hemostasis with clip in people with Peptic Ulcer Hemorrhage, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Endoscopic hemostasis with clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2020to 1 Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 20 to 80
- The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
- American Society of Anesthesiologist (ASA) Physical Status 1 - 3
- Patients with adequate patient compliance and adequate geographical distance for follow-up. character
Who cannot join
- Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
- Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
- Patients with insufficient clinical information
- Pregnant or lactating patients
- Patients or guardians who have not obtained informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ClearEndoclip Versus EZ Clip for the Hemostasis of Upper Gastrointestinal Ulcer Bleeding: an Open-label, Non-inferiority, Randomized, Multicenter Trial
We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea.
- Research hypothesis and purpose
- This study was designed to prove the hypothesis that the hemostatic effect of newly developed endoscopic clip (ClearEndoclip, FineMedix, Taegu, Korea) is not inferior to that of EZ clip (Olympus, Tokyo, Japan) in the treatment of hemostasis for patients who visited the upper gastrointestinal ulcer bleeding.
- This study was designed as a multi-center (9 institutions), open-labelled, randomized comparative clinical trial (1:1 ratio).
Read the detailed description
- Design of this study
- Stratified randomization is performed, and the variable used for stratification is the patient's age (65 years or older, 65 years or less).
- The existing clip (control) and the domestic clip (experimental group) are divided by the block size randomization method of size 4 for each floor.
- Patients and Methods
- inclusion criteria
- Men and women aged 20 to 80
- The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
- American Society of Anesthesiologist (ASA) Physical Status 1 - 3
- Patients with adequate patient compliance and adequate geographical distance for follow-up. character
- exclusion criteria
- Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
- Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
- Patients with insufficient clinical information
- Pregnant or lactating patients
- Patients or guardians who have not obtained informed consent
- The number of patients
- The number of subjects was calculated based on a non-inferiority study
- The reported rate of rebleeding after hemostasis using the conventional hemoclip: about 5%.
- 2.5% one-sided test, 80% power, and non-inferiority limit set to 10%
- 75 subjects are required for each group, and 83 subjects are required if the drop rate is assumed to be 10%.
- Methods
- After completing an informed consent form to the subjects who wish to participate in the study at the time of visit, basic clinical variables are checked.
- First endoscopic hemostasis is performed. In this time, EZ clip is used for the subjects assigned to the control group, and ClearEndoclip is used for the subjects assigned to the experimental group to target blood vessels in the ulcer. At the same time, clinical parameters related to hemostasis are recorded.
- After hemostasis is performed, rebleeding and complications are tracked up to 30 days after the procedure.
- Variables to be collected
- At the time of visit: age, gender, height, weight, drug use (anticoagulant/antiplatelet agents, NSAIDs, steroids), underlying diseases (cirrhosis, diabetes, end-stage renal failure, heart disease, lung disease), hematological data, hemoglobin, Complete Rockall score
- At the time of primary endoscopic hemostasis: location of ulcer, size of ulcer, size of exposed blood vessel (based on 2mm), forrest classification, total number of clips used, number of failed clips, usage and usage of epinephrine, procedure time (minutes) , Clip hemostasis success, treatment after clip hemostasis failure
- After hemostasis: rebleeding (within 7 days), number of clips and bleeding from the follow-up endoscope after 48 hours, death within 30 days, ICU hospitalization date, total hospitalization date, complications of hemostasis, Helicobacter pylori
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Endoscopic hemostasis with clip
- Keywords
- peptic ulcer, hemorrhage, stomach, duodenum
- Medical subject headings
- Peptic Ulcer Hemorrhage, Peptic Ulcer, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic hemostasis with clipDevice
This intervention is performed as the following orders.
- The tip of endoscope is accessed to a bleeding site.
- The accurate visualization of bleeding site is done.
- A sheath of delivery system of clip is inserted through a working channel of endoscope.
- The end of clip is opened in front of the bleeding site. If needed, clip could be rotated to adjust to a bleeding target.
- The both ends of clip are placed on both sides of a bleeding site.
- If bleeding is still continued, additional placements of clip are tried until bleeding stops.
| Study group | Role | What they receive |
|---|---|---|
| ClearEndoclip | Experimental | This arm is a group in whom ClearEndoclip would be used for the treatment of bleeding. Receives: Device: Endoscopic hemostasis with clip |
| EZ clip | Active comparator | This arm is a group in whom EZ clip would be used for the treatment of bleeding. Receives: Device: Endoscopic hemostasis with clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate after endoscopic hemostasis
The rate of rebleeding at the site of bleeding within 7 days after the first endoscopic hemostasis, which should be identified endoscopically.
Measured: upto 7 days
Secondary outcomes (2)
Satisfaction scores of the operator and the assistant
the degree in ten-scale in terms of an endoscopic visibility to a bleeding site and the easiness of use. the minimum: 1(worst value), the maximum: 10(best)
Measured: during endoscopic procedure
Failure rate of clip installation
Ratio of unsuccessful clips to total number of clips used
Measured: during endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start24 Aug 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies 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
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Keimyung University Dongsan Medical Center, Korea University Anam Hospital, National Cancer Center, Korea, Nowon Eulji Medical Center, Pusan National University Hospital, Wonju Severance Christian Hospital, Inha University Hospital, Presbyterian medical center
- Responsible party
- Principal investigator, Sun Gyo Lim, MD, Ajou University School of Medicine
- Investigators
- Sun Gyo Lim, Principal investigator, Department of Gastroenterology, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536428
- Sponsor's protocol ID
- AJIRB-DEV-DE2-20-148
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 2 Sep 2020
- 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClearEndoclip Versus EZ Clip for the Hemostasis of Upper Gastrointestinal Ulcer Bleeding: an Open-label, Non-inferiority, Randomized, Multicenter Trial
- ClinicalTrials.gov ID
- NCT04536428
- Acronym / sponsor ID
- AJIRB-DEV-DE2-20-148
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- peptic ulcer, hemorrhage, stomach, duodenum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Keimyung University Dongsan Medical Center, Korea University Anam Hospital, National Cancer Center, Korea, Nowon Eulji Medical Center, Pusan National University Hospital, Wonju Severance Christian Hospital, Inha University Hospital, Presbyterian medical center
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 2 Sep 2020 (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.
We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea.
- Research hypothesis and purpose
- This study was designed to prove the hypothesis that the hemostatic effect of newly developed endoscopic clip (ClearEndoclip, FineMedix, Taegu, Korea) is not inferior to that of EZ clip (Olympus, Tokyo, Japan) in the treatment of hemostasis for patients who visited the upper gastrointestinal ulcer bleeding.
- This study was designed as a multi-center (9 institutions), open-labelled, randomized comparative clinical trial (1:1 ratio).
Detailed description
- Design of this study
- Stratified randomization is performed, and the variable used for stratification is the patient's age (65 years or older, 65 years or less).
- The existing clip (control) and the domestic clip (experimental group) are divided by the block size randomization method of size 4 for each floor.
- Patients and Methods
- inclusion criteria
- Men and women aged 20 to 80
- The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
- American Society of Anesthesiologist (ASA) Physical Status 1 - 3
- Patients with adequate patient compliance and adequate geographical distance for follow-up. character
- exclusion criteria
- Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
- Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
- Patients with insufficient clinical information
- Pregnant or lactating patients
- Patients or guardians who have not obtained informed consent
- The number of patients
- The number of subjects was calculated based on a non-inferiority study
- The reported rate of rebleeding after hemostasis using the conventional hemoclip: about 5%.
- 2.5% one-sided test, 80% power, and non-inferiority limit set to 10%
- 75 subjects are required for each group, and 83 subjects are required if the drop rate is assumed to be 10%.
- Methods
- After completing an informed consent form to the subjects who wish to participate in the study at the time of visit, basic clinical variables are checked.
- First endoscopic hemostasis is performed. In this time, EZ clip is used for the subjects assigned to the control group, and ClearEndoclip is used for the subjects assigned to the experimental group to target blood vessels in the ulcer. At the same time, clinical parameters related to hemostasis are recorded.
- After hemostasis is performed, rebleeding and complications are tracked up to 30 days after the procedure.
- Variables to be collected
- At the time of visit: age, gender, height, weight, drug use (anticoagulant/antiplatelet agents, NSAIDs, steroids), underlying diseases (cirrhosis, diabetes, end-stage renal failure, heart disease, lung disease), hematological data, hemoglobin, Complete Rockall score
- At the time of primary endoscopic hemostasis: location of ulcer, size of ulcer, size of exposed blood vessel (based on 2mm), forrest classification, total number of clips used, number of failed clips, usage and usage of epinephrine, procedure time (minutes) , Clip hemostasis success, treatment after clip hemostasis failure
- After hemostasis: rebleeding (within 7 days), number of clips and bleeding from the follow-up endoscope after 48 hours, death within 30 days, ICU hospitalization date, total hospitalization date, complications of hemostasis, Helicobacter pylori
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClearEndoclip | Experimental | Device: Endoscopic hemostasis with clipThis arm is a group in whom ClearEndoclip would be used for the treatment of bleeding. |
| EZ clip | Active comparator | Device: Endoscopic hemostasis with clipThis arm is a group in whom EZ clip would be used for the treatment of bleeding. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 20 to 80
- The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
- American Society of Anesthesiologist (ASA) Physical Status 1 - 3
- Patients with adequate patient compliance and adequate geographical distance for follow-up. character
Key exclusion criteria (5 listed)
- Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
- Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
- Patients with insufficient clinical information
- Pregnant or lactating patients
- Patients or guardians who have not obtained informed consent
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 |
|---|---|---|
| Endoscopic hemostasis with clipThis intervention is performed as the following orders. * The tip of endoscope is accessed to a bleeding site. * The accurate visualization of bleeding site is done. * A sheath of delivery system of clip is inserted through a working channel of endoscope. * The end of clip is opened in front of the bleeding site. If needed, clip could be rotated to adjust to a bleeding target. * The both ends of clip are placed on both sides of a bleeding site. * If bleeding is still continued, additional placements of clip are tried until bleeding stops. | Device | ClearEndoclip, EZ clip |
Primary outcome
Rebleeding rate after endoscopic hemostasis
Time frame: upto 7 days
The rate of rebleeding at the site of bleeding within 7 days after the first endoscopic hemostasis, which should be identified endoscopically.
2 secondary outcomes
Satisfaction scores of the operator and the assistant
Time frame: during endoscopic procedure
Failure rate of clip installation
Time frame: during endoscopic procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Related trials for Peptic Ulcer Hemorrhage
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
RecruitingPhase 2
Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers
Peptic Ulcer Bleeding
Not yet recruiting
Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding
Bleeding
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
Recruiting
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Acute Gastrointestinal Bleeding
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.
Sun Gyo Lim principal investigator
Department of Gastroenterology, Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic hemostasis with clip in people with Peptic Ulcer Hemorrhage, run by Ajou University School of Medicine 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 4 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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?
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?
Rebleeding rate after endoscopic hemostasis (time frame: upto 7 days). 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 Sep 2020.