Pilot StudyNCT06285955
Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips
An observational study of Pilot Study and Clips, run by Beijing 302 Hospital at 1 site in China.
Trial summary
Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pilot Study, Clips
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 31 Jul 2024
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Meet the inclusion and exclusion criteria.
Who may be able to join
- 1. Gastrointestinal lesions that require clips include non-variceal upper gastrointestinal bleeding, post-endoscopic submucosal dissection (ESD) lesions in the gastrointestinal tract, fistulas, diverticula, perforations, and anchoring of self-expanding metal stents.
- 2. Expected survival greater than 30 days;
- 3. Written informed consent.
Who cannot join
- 1. Patients with diffuse gastrointestinal lesions, such as Crohn's disease and ulcerative colitis;
- 2. Patients who clearly require surgical intervention;
- 3. Serious cardio-pulmonary, hepatic or renal disease;
- 4. Intolerance to endoscopy;
- 5. Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
The fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
About this study
Official title: Clinical Trial of Metal-reinforced Teeth Designed for Endoscopic Clips to Validate the Safety, Feasibility and Effectiveness
Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate.
Read the detailed description
With the advancement of endoscopic technology, gastrointestinal defects following endoscopic submucosal dissection (ESD), mucosal resection (EMR), and full-thickness resection (EFTR), as well as complications such as gastrointestinal bleeding, diverticula, fistulas, perforations, and even fixation of esophageal stents, can gradually be treated through endoscopic procedures. This approach avoids surgical incisions and reduces patient recovery time. Traditional endoscopic hemoclips have limited application due to constraints such as arm extension distance, size of the clip's front teeth, and closing force. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcome measures include technical success rate and clinical success rate. Additionally, the investigators closely monitor procedure time, the number of clip uses during the procedure, and postoperative adverse events during follow-ups.
- Conditions
- Pilot Study, Clips
- Keywords
- clips, gastrointestinal diseases, Metal-reinforced teeth, perforation, fistula, gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Diseases, Fistula, Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Clinical success rate refers to the ratio of cases in which gastrointestinal problems have been resolved and/or endoscopic or radiological data show complete closure of the defect.
Measured: 14 to 30 days
Secondary outcomes (3)
Technical success rate
Technical success rate refers to the ratio of cases in which a sufficient number of clips are placed and released.
Measured: The operation day
Delayed bleeding rate
The delayed bleeding rate is defined as the ratio of bleeding that necessitates emergency endoscopic hemostasis or transfusion, or the presence of hemoglobin loss of ≥2 g/dL after therapy.
Measured: 14 days
Delayed perforation rate
The delayed perforation rate is defined as the ratio of the presence of free air on abdominal CT or radiography after the completion of the procedure in patients without perforation during EMR/ESD and no symptoms of peritoneal irritation after therapy.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Feb 2024
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilot StudyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, MD, Principal investigator, The Fifth Medical Center of Chinese PLA General Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285955
- Sponsor's protocol ID
- 307-reinforced teeth
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Metal-reinforced Teeth Designed for Endoscopic Clips to Validate the Safety, Feasibility and Effectiveness
- ClinicalTrials.gov ID
- NCT06285955
- Acronym / sponsor ID
- 307-reinforced teeth
- Conditions
- Pilot Study, Clips
- Keywords
- clips, gastrointestinal diseases, Metal-reinforced teeth, perforation, fistula, gastrointestinal bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 29 Feb 2024 (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.
Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate.
Detailed description
With the advancement of endoscopic technology, gastrointestinal defects following endoscopic submucosal dissection (ESD), mucosal resection (EMR), and full-thickness resection (EFTR), as well as complications such as gastrointestinal bleeding, diverticula, fistulas, perforations, and even fixation of esophageal stents, can gradually be treated through endoscopic procedures. This approach avoids surgical incisions and reduces patient recovery time. Traditional endoscopic hemoclips have limited application due to constraints such as arm extension distance, size of the clip's front teeth, and closing force. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcome measures include technical success rate and clinical success rate. Additionally, the investigators closely monitor procedure time, the number of clip uses during the procedure, and postoperative adverse events during follow-ups.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meet the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 1. Gastrointestinal lesions that require clips include non-variceal upper gastrointestinal bleeding, post-endoscopic submucosal dissection (ESD) lesions in the gastrointestinal tract, fistulas, diverticula, perforations, and anchoring of self-expanding metal stents.
- 2. Expected survival greater than 30 days;
- 3. Written informed consent.
Key exclusion criteria (5 listed)
- 1. Patients with diffuse gastrointestinal lesions, such as Crohn's disease and ulcerative colitis;
- 2. Patients who clearly require surgical intervention;
- 3. Serious cardio-pulmonary, hepatic or renal disease;
- 4. Intolerance to endoscopy;
- 5. Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical success rate
Time frame: 14 to 30 days
Clinical success rate refers to the ratio of cases in which gastrointestinal problems have been resolved and/or endoscopic or radiological data show complete closure of the defect.
3 secondary outcomes
Technical success rate
Time frame: The operation day
Delayed bleeding rate
Time frame: 14 days
Delayed perforation rate
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Yan Liu, MD principal investigator
The Fifth Medical Center of Chinese PLA General Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilot Study and Clips, run by Beijing 302 Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 23 Aug 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical success rate (time frame: 14 to 30 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 23 Aug 2024.