An observational study in Gastric Disease, sponsored by Suzhou Kerui Medical Technology Co., Ltd. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Suzhou Kerui Medical Technology Co., Ltd · Observational
Among 16 studies in Stomach Diseases with a site in China — 2 open to participants now, 4 under way, none of them phase 3. Stomach Diseases · China.
Among the 16 studies in Stomach Diseases with a site in China, this one is one of 2 that started in 2024, is one of 5 observational ones, and was the 15th registered.
53 studies on the registry are indexed under Stomach Diseases; 6 are open to participants now.
Browse Stomach Diseases studies →2 of the 16 studies in Stomach Diseases with a site in China are open now. Recruiting first, the newest first:
Shandong University · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2 Stomach Diseases studies recruiting now, 0 (0%) set no upper age limit and 1 (50%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 3
First in 2009; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 195 is close to the median of 213 across 13 observational studies indexed under Stomach Diseases.
Median enrollment 252 across the 11 interventional studies, 951 across the 5 observational. Of the 8 that completed or were terminated, 2 (25%) have results posted.
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1 of 16 have an industry lead sponsor. The 9 most frequent:
Suzhou Kerui Medical Technology Co., Ltd is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Suzhou Kerui Medical Technology Co., Ltd has 1 study filed under Stomach Diseases — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Stomach Diseases with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.
The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.
Patients who need open or endoscopic surgery using the study device for resection, transection and anastomosis for liver, bronchial tissue, stomach and intestines. Those who meet the inclusion criteria and don't meet the exclusion criteria will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
Exclusion Criteria:
patients with to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
to use the study device for excision, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery.
anastomosis success rate
According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100%
Time frame: within six months after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Dec 2024, 4 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Suzhou Kerui Medical Technology Co., Ltd