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Standard of Care Arm for Colorectal Cancer (SH-SOC23 Trial)

N/A
Recruiting
Research Sponsored by SafeHeal Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

SH-SOC23 Trial Summary

This trial aims to evaluate the safety of a common cancer treatment called low anterior resection (LAR). The goal is to define major complications associated with this treatment as a way to compare its safety with

Who is the study for?
This trial is for adults over 18 who are set to have a specific surgery (low anterior resection with diverting loop ileostomy) for colorectal cancer. They should be relatively active and able to care for themselves (ECOG ≤ 2), and willing to follow the study's procedures and visits.Check my eligibility
What is being tested?
The SafeHeal study is testing the safety of standard low anterior resection treatment for colorectal cancer by defining major complications. This will help compare its safety against other treatments by creating a new single safety endpoint.See study design
What are the potential side effects?
Since this trial focuses on assessing safety, side effects may include typical surgical complications such as infection, bleeding, pain at the surgery site, bowel obstruction or leakage from where the intestine was sewn together.

SH-SOC23 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Early anastomotic complications
Overall major complications

SH-SOC23 Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard of Care ArmExperimental Treatment1 Intervention
Diverting loop ileostomy following low anterior resection of colorectal cancer

Find a Location

Who is running the clinical trial?

SafeHeal IncLead Sponsor
2 Previous Clinical Trials
62 Total Patients Enrolled
Marcos Velez-DuranStudy DirectorSafeHeal Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist participants for this trial?

"Affirmative. The details on clinicaltrials.gov affirm that this medical investigation is presently enrolling volunteers. It was originally listed on January 1st, 2024 and the latest revision was made on March 6th, 2024. Recruitment aims to include a total of 196 participants across three designated sites."

Answered by AI

How many participants are currently enrolled in this medical research study?

"Indeed, the details on clinicaltrials.gov indicate an ongoing recruitment drive for participants in this medical trial. The study was first listed on January 1st, 2024, and recently revised on March 6th of the same year. A total of 196 individuals need to be enrolled from three distinct locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SafeHeal Diverting Ileostomy Pivotal Study
2024. "SafeHeal Diverting Ileostomy Pivotal Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152276.
~131 spots leftby Dec 2025
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