SH-SOC23: SafeHeal Diverting Ileostomy Pivotal Study

Sponsor

SafeHeal Inc (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06152276

Collaborator

(none)

196

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Stoma Ileostomy	Other: Diverting loop ileostomy	N/A

Detailed Description

The data from this study could serve as the historical control arm data of a SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-3) Pivotal Study designed as a prospective, non-randomized, sequential, controlled, multicenter trial comparing the investigational device, the next generation Colovac Anastomosis Protection Device, to the standard of care (SOC), diverting ostomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This study is a prospective, non-controlled, multicenter trial on the standard of care which is diverting ostomy.This study is a prospective, non-controlled, multicenter trial on the standard of care which is diverting ostomy.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard of Care Arm Diverting loop ileostomy following low anterior resection of colorectal cancer	Other: Diverting loop ileostomy Diverting loop ileostomy following low anterior resection of colorectal cancer

Arm

Intervention/Treatment

Other: Standard of Care Arm

Diverting loop ileostomy following low anterior resection of colorectal cancer

Other: Diverting loop ileostomy

Diverting loop ileostomy following low anterior resection of colorectal cancer

Outcome Measures

Primary Outcome Measures

Early anastomotic complications [9 months]
Early anastomotic complications
Overall major complications [9 months]
Major complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients (18 years of age or older)
Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria:

Preoperative

History of left colitis
Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)
Pregnant or nursing female subject
Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol described procedures or interfere with the interpretation of study results including, but not limited to:
Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
Immunodeficiency (CD4+ count < 500 CU MM)
Systemic steroid therapy within the past 6 months
Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, or carcinomatosis
Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
Severe malnutrition defined as 10% weight loss within 3 months prior to enrollment.
The subject is currently participating in another investigational drug or device study

Intraoperatively:

Occurrence of any of the following during the colorectal surgery:
Blood loss (>750 cc)
Blood transfusion
Any new sign of bowel ischemia
Positive air leak test
Inadequate bowel preparation
Anastomosis location greater than 10 cm from the anal verge
Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

SafeHeal Inc

Investigators

Study Director: Marcos Velez-Duran, SafeHeal Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SafeHeal Inc

ClinicalTrials.gov Identifier:

NCT06152276

Other Study ID Numbers:

SH-SOC23

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Nov 30, 2023