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CC BY 4.0 · Endosc Int Open 2025; 13: a26502692
DOI: 10.1055/a-2650-2692
Original article

Single-center, prospective study evaluating safety and efficacy of a new endoscopic hemostat system in non-variceal upper gastrointestinal bleeding

Autoren

  • Hardik Rughwani  ‡

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Rajat Garg  ‡

    2   Dept. of Gastroenterology and Hepatology, Cleveland Clinic Foundation, Cleveland, United States (Ringgold ID: RIN2569)

  • Mohammed Faisal Habeeb

    3   Dept. of Medicine, NHS Ayrshire and Arran, Ayr, United Kingdom of Great Britain and Northern Ireland (Ringgold ID: RIN1442)

  • Nitin Jagtap

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Zaheer Nabi

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Pradev Inavolu

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Shreevyshnavi Aachi

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Mohan Ramchandani

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Darisetty Santosh

    4   Dept. of Anaesthesia, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Gauri Nayak

    5   Dept. of Medical Gastroenterology, TNMC & BYL Nair Ch. Hospital, Mumbai, India (Ringgold ID: RIN29566)

  • Sundeep Lakhtakia 

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

  • Nageshwar Reddy

    1   Dept. of Medical Gastroenterology, Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India (Ringgold ID: RIN78470)

Gefördert durch: Hemostasis, LLC Clinical Trial: Registration number (trial ID): CTRI/2021/12/038478, Trial registry: Clinical Trials Registry India (http://www.ctri.nic.in/Clinicaltrials), Type of Study: Prospective
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Abstract

Background and study aims

Endoscopic spray therapy has been shown to be effective and safe in managing upper gastrointestinal bleeding (UGIB). We aimed to evaluate safety and efficacy of the novel powder-based Resolv Endoscopic Hemostat System in managing UGIB.

Patients and methods

This was a single-center, prospective, single-arm study conducted from July 2022 to February 2023. It aimed to evaluate safety and efficacy of a novel plant-based polysaccharide, the Resolv Endoscopic Hemostat System, in achieving hemostasis in adult patients diagnosed with non-variceal upper gastrointestinal bleeding (UGIB) (Forest 1b/oozing bleeding). Participants in this study underwent endoscopy and received monotherapy treatment using the Resolv Endoscopic Hemostat System. Outcomes of interest were adverse events (AEs) related to the device within 72 hours and 30 days, immediate hemostasis, and rebleeding rates within 72 hours of the index procedure.

Results

A total of 59 patients (71.2% men) with mean age of 55.3 ± 14.2 years were included in the study. Causes of bleeding included post-polypectomy (n = 35, 59.3%), gastric ulcers (n = 13, 22%), malignant tumor (n = 4, 6.8%), post-biopsy-related needing hemostasis (n = 3, 5.1%), congestive gastropathy (n = 2, 3.4%), duodenal ulcer (n = 1, 1.7%), and portal hypertensive duodenopathy-related (n = 1, 1.7%). Resolv achieved a 100% success rate for immediate hemostasis with a 72-hour rebleeding rate of 5.1%. There were no AEs related to the device or mortality.

Conclusions

Resolv Endoscopic Hemostat System is a safe and effective device for achieving immediate hemostasis in patients with non-variceal upper gastrointestinal bleeding. Future studies are required to examine its widespread adoption and applicability.

Keywords

Endoscopy Upper GI Tract - Non-variceal bleeding - Ulcers (peptic and other) - Endoscopy Small Bowel - Small intestinal bleeding


Publikationsverlauf

Eingereicht: 06. April 2025

Angenommen nach Revision: 23. Juni 2025

Accepted Manuscript online:
07. Juli 2025

Artikel online veröffentlicht:
29. Juli 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Bibliographical Record
Hardik Rughwani, Rajat Garg, Mohammed Faisal Habeeb, Nitin Jagtap, Zaheer Nabi, Pradev Inavolu, Shreevyshnavi Aachi, Mohan Ramchandani, Darisetty Santosh, Gauri Nayak, Sundeep Lakhtakia, Nageshwar Reddy. Single-center, prospective study evaluating safety and efficacy of a new endoscopic hemostat system in non-variceal upper gastrointestinal bleeding. Endosc Int Open 2025; 13: a26502692.
DOI: 10.1055/a-2650-2692
 

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