HemosprayTM for Gastrointestinal Bleeding From Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Title: The efficacy of hemostatic powder TC-325 versus standard endoscopic treatment for gastrointestinal bleeding from malignancy; a multi-center randomized trial

Background: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. It has a trend to be an effective hemostasis method for active GI bleeding from tumor, however, in view of the lack of RCTs and large-scale studies, the efficacy of TC-325 is still inconclusive.

Objective: To evaluate the efficacy of TC325 in endoscopic hemostasis treatment for malignant gastrointestinal hemorrhage.The 24-hour, 72-hour, 30-day, 90-day and 180-day rebleeding rate were assessed as the outcomes of treatment as well as 6-month mortality.

Study design: Single-blinded, multi-center, randomized-control trial study The intervention (experimental) arm: TC-325 alone (define failure if continued bleeding despite application of 1 syringes) The control arm: Standard of (traditional) endoscopic treatments

\*\* Crossover is possible. Inclusion criteria: Patients with acute upper or lower GIB from a lesion that is actively bleeding at index endoscopy (spurting or oozing) and is suspected to be malignant or diagnosed as malignancy from previous tissue diagnosis.

Exclusion criteria: Patients less than 18 years old, previously included in the trial, ECOG score 3 or 4, pregnancy/lactation, and/or bleeding from GI sources suspected of not being malignant. If an endoscopist is unsure of the malignant likelihood of the lesion, he/she will not be enrolled.

Sample size: 112 in total

Duration of participation for each volunteer: 180 days

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

NCT02135627

MALIGNANT GASTROINTESTINAL BLEEDING

COMPLETED NA

Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

NCT02820077

Gastrointestinal Hemorrhage Gastrointestinal Neoplasms

TERMINATED NA

Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

NCT03066700

Death

COMPLETED

Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding

NCT02732483

Bleeding at Gastric Cancer

UNKNOWN PHASE2

Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study

NCT03169569

High-risk Patients for Post-ESD Bleeding

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Bleeding From Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At the time of initial early endoscopy, following fulfillment of patient and bleeding lesion eligibility, central randomization is carried out in a 1:1 ratio, in blocks of 4. The confidential centralized random numbers allocation is obtained by using REDCap (https://www.project-redcap.org/), a web based platform available to all participating centres. An independent staff member maintained the randomization numbers in sealed opaque envelopes. After obtaining a written informed from an eligible patient, the gastroenterologists who were blinded to the sequence of treatment opened the next numbered sealed envelope with treatment allocation.Randomization is stratified by location of bleed (upper versus lower GI tract), considering the lack of comparative outcomes data in the literature, thus balancing known and unknown confounding more completely

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Due to the nature of the intervention and control arms, blinding of the endoscopist is not possible (visual clues as to the nature of endoscopic treatment are evident and no sham procedure can be delivered since both are active treatment groups). However, in order to minimize possible patient/observer bias, any research team member or investigator assessing the patient after the initial endoscopy and involved in data collection or analysis, as well as the patient, and research nurse will be blinded to treatment allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TC-325

The intervention (experimental) arm patients are treated initially with TC-325 alone. Treatment failure for TC-325 is defined as endoscopists cannot achieve hemostasis with 1 syringe (20gm) of TC-325.

Group Type EXPERIMENTAL

TC-325

Intervention Type DEVICE

TC-325 compounds of inorganic, non-absorbable powder which acts locally at the mucosal tissue. When spraying the powder on to the blood, it will become a stable barrier sheet because of the effect of clotting factors accumulation and, then the normal healing process can be promoted.

Traditional treatment (Control group)

Control group patients initially receive usual standard of (traditional) endoscopic treatment (SET) as defined by injection therapy with another modality or sole/combination use of thermal or mechanical modalities. Crossovers to either treatment arm are permitted if immediate haemostasis does not achieved with standard endoscopic or TC-325 application.Treatment failure of SET is defined as endoscopists cannot achieve hemostasis by selected SET.

Group Type ACTIVE_COMPARATOR

TC-325

Intervention Type DEVICE

TC-325 compounds of inorganic, non-absorbable powder which acts locally at the mucosal tissue. When spraying the powder on to the blood, it will become a stable barrier sheet because of the effect of clotting factors accumulation and, then the normal healing process can be promoted.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TC-325

TC-325 compounds of inorganic, non-absorbable powder which acts locally at the mucosal tissue. When spraying the powder on to the blood, it will become a stable barrier sheet because of the effect of clotting factors accumulation and, then the normal healing process can be promoted.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HemosprayTM

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Acute upper or lower gastrointestinal bleeding
* Endoscopy shows actively bleeding at index endoscopy (spurting or oozing)
* Bleeding from malignancy

Exclusion Criteria

* Less than 18 years old
* Previously included in the trial
* Eastern Cooperative Oncology Group (ECOG) score 3 or 4
* Pregnancy/lactation
* Bleeding from GI sources suspected of not being malignant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No