Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.
Surg Endosc
; 36(12): 9123-9128, 2022 Dec.
Article
in English
| MEDLINE | ID: covidwho-2128651
ABSTRACT
BACKGROUND:
The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing.METHODS:
The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices.RESULTS:
We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity.CONCLUSIONS:
The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Sutures
/
Suture Techniques
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Surg Endosc
Journal subject:
Diagnostic Imaging
/
Gastroenterology
Year:
2022
Document Type:
Article
Affiliation country:
S00464-022-09392-7
Similar
MEDLINE
...
LILACS
LIS