FindTrial
Sign In

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).

A Single Center, Prospective, Open-Label, Single-Arm Study To Evaluate The Safety And Efficacy Of The Resolv® Endoscopic Hemostat System In Achieving Acute Hemostasis In Adult Subjects Diagnosed With Non-Variceal Upper Gastrointestinal Bleeding.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038478
Enrollment
60
Registered
2021-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Resolv® Endoscopic Hemostat System: The Resolv® Endoscopic Hemostat System is a sterile prescription device intended for use under the care of a health care professional for hemostasis

Sponsors

Hemostasis LLC
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Subjects is 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 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

Design outcomes

Primary

MeasureTime frame
To evaluate the safety of the Resolv® Endoscopic Hemostat System.Timepoint: 72 hours and 30 days post-op.—

Secondary

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactDr D Nageshwar Reddy

Asian Institute of Gastroenterology

aigindia@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026