Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285955
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2024-02-01
Brief Title:
Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips
Sponsor:
Beijing 302 Hospital
Organization:
Beijing 302 Hospital
Study Overview
Official Title:
Clinical Trial of Metal-reinforced Teeth Designed for Endoscopic Clips to Validate the Safety Feasibility and Effectiveness
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 clips 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None