A Clinical study to determine whether RESOLV® Endoscopic Hemostat System is safe and effective at achieving hemostasis (stopping bleeding) in adult subjects diagnosed with non-variceal gastrointestinal bleeding (bleeding from just past your throat to just past your stomach).

Not Applicable

Completed

• Conditions: Health Condition 1: K274- Chronic or unspecified peptic ulcer, site unspecified, with hemorrhage

• Registration Number: CTRI/2021/12/038478
• Lead Sponsor: Hemostasis LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-06-02
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

1. Clinically known/confirmed GI bleeding – non variceal UGIB with bleeding severity of Forrest 1b, such as, post EMR, ESD, , or tumor bleed

2. Subject is 18-90 years old

3. Subject or legally authorized representative provides written authorization and/or consent

4. Subject can be followed up for at least 72 hours post-operatively and then at 30 days

Exclusion Criteria

1. Subjects is <18 years old

2. Subject (or legally authorized representative) is unwilling or unable to provide informed consent

3. NSAIDs, anticoagulants and antiplatelet agents cannot be discontinued prior to and for at least 72 hours after endoscopy

4. Subject is pregnant or lactating

5. Hemodynamic instability (blood pressure <90/60mm Hg and or pulse >110/mt at the time of endoscopy

6. Subject who has known hypersensitivity to potato starch

7. Presence of vascular shunt

8. Subject has Uncorrected coagulopathy

9. Peptic ulcers previously treated with other modalities (less than a week prior to the study)

10. Contraindications for endoscopy

11. Known decompensated chronic liver disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the Resolv® Endoscopic Hemostat System.Timepoint: 72 hours and 30 days post-op.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of use of the Resolv© Endoscopic Hemostat System in control of non-variceal GI bleed.Timepoint: 72 hours and 30 days post-op.