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Updated: Sep 2, 2025
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Author Spotlight: An Efficient and Robust Software for Automated Fusion of Multiple Preclinical Imaging Modalities
Published on: October 27, 2023
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Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.
Jennifer L Maranki1, Steven D Schwaitzberg2, Reem Z Sharaiha3
1Division of Gastroenterology and Hepatology, Department of Medicine, Penn State Hershey Medical Center, Hershey, PA, USA. jmaranki@pennstatehealth.psu.edu.
Surgical Endoscopy
|August 3, 2022
Summary
This study evaluated a novel endoscopic suturing device for tissue approximation, finding it safe and effective in real-world applications like bariatric revision and obesity treatment. The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) supports its clinical role.
Area of Science:
- Gastroenterology
- Endoscopic Surgery
- Medical Device Technology
Background:
- Novel endoscopic technologies often face challenges with adoption due to uncertainty and lack of standardization.
- The OverStitch™ endoscopic suturing device offers new possibilities for tissue apposition in endoscopic procedures.
Purpose of the Study:
- To assess the safety, effectiveness, and durability of endoscopic suturing for tissue approximation.
- To evaluate the real-world application of a novel endoscopic suturing device in bariatric revision and endoprosthetic device fixation.
Main Methods:
- Development and execution of a multicenter, non-randomized, Phase 4 postmarketing registry (ES Registry).
- Pragmatic data collection on the use of the OverStitch™ device for tissue apposition.
Main Results:
- Preliminary data indicate the novel endoscopic suturing device is safe and effective.
- The registry captured real-world use of the device in obesity treatment and bariatric revision.
Conclusions:
- The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) effectively captured pragmatic, real-world data.
- Findings support the established role of endoscopic suturing in clinical practice.
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