Trial Outcomes & Findings for Cleancision IntRaoperative Contamination prEvention Study (NCT NCT02413879)

NCT ID: NCT02413879

Last Updated: 2017-07-27

Results Overview

Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 108 participants
• Primary outcome timeframe: 1 day (end of the procedure and removal of the investigational device)
• Results posted on: 2017-07-27

Participant Flow

There were 11 subjects in an initial study phase conducted at a single-center. The protocol was modified following this phase. Also, 11 subjects were in a pre-specified roll-in phase. The 22 participants in the Initial Study Phase and Roll-In Phase account for the discrepancy between Protocol Enrollment and Participant Flow "Started" value.

Participant milestones

Measure	Treatment Group All study subjects were treated using the CleanCision device.
Overall Study STARTED	86
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cleancision IntRaoperative Contamination prEvention Study

Baseline characteristics by cohort

Measure	Treatment Arm n=86 Participants All study subjects will be treated using the CleanCision device.
Age, Continuous	62.4 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=5 Participants
Race/Ethnicity, Customized White	81 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants
BMI	29.0 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants
Medical History IBD	14 Participants n=5 Participants
Medical History Colorectal Cancer	33 Participants n=5 Participants
Medical History Hypertension	46 Participants n=5 Participants
Medical History Diabetes	19 Participants n=5 Participants
Medical History History of Smoking	46 Participants n=5 Participants
Medical History Steroid or other immunosuppressant within 1 month	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day (end of the procedure and removal of the investigational device)

Population: Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.

Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge

Outcome measures

Measure	Treatment Arm n=84 Participants All study subjects will be treated using the CleanCision device.
Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) Contamination Rate on Exposed Surface	33.3 % of participants with contamination
Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) Contamination Rate on Protected Incision Edge	9.5 % of participants with contamination

PRIMARY outcome

Timeframe: 30 days

Population: All subjects within the Treatment arm were analyzed (Intention-to-treat).

Incidence of Serious Adverse Events directly attributable to the device

Outcome measures

Measure	Treatment Arm n=86 Participants All study subjects will be treated using the CleanCision device.
Safety (Serious Adverse Events Directly Attributable to the Device)	0 Participants

SECONDARY outcome

Timeframe: 1 day (end of the procedure and removal of the investigational device)

Population: Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.

Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge

Outcome measures

Measure	Treatment Arm n=84 Participants All study subjects will be treated using the CleanCision device.
Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) Contamination Rate on Exposed Surface	34.5 % of participants with contamination
Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) Contamination Rate on Protected Incision Edge	11.9 % of participants with contamination

Adverse Events

Treatment Arm

Serious events: 17 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=86 participants at risk All study subjects will be treated using the CleanCision device.
Blood and lymphatic system disorders Anaemia	1.2% 1/86 • Number of events 1 • 30 days
Cardiac disorders Myocardial infarction	2.3% 2/86 • Number of events 2 • 30 days
Gastrointestinal disorders Abdominal pain	1.2% 1/86 • Number of events 1 • 30 days
Gastrointestinal disorders Ileus	3.5% 3/86 • Number of events 3 • 30 days
Gastrointestinal disorders Intestinal obstruction	1.2% 1/86 • Number of events 1 • 30 days
Gastrointestinal disorders Mesenteric vein thrombosis	1.2% 1/86 • Number of events 1 • 30 days
Gastrointestinal disorders Vomiting	1.2% 1/86 • Number of events 1 • 30 days
General disorders Pain	1.2% 1/86 • Number of events 1 • 30 days
Infections and infestations Infection	2.3% 2/86 • Number of events 2 • 30 days
Injury, poisoning and procedural complications Excoriation	1.2% 1/86 • Number of events 1 • 30 days
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	1.2% 1/86 • Number of events 1 • 30 days
Renal and urinary disorders Urinary retention	1.2% 1/86 • Number of events 1 • 30 days
Vascular disorders Haematoma	1.2% 1/86 • Number of events 1 • 30 days
Vascular disorders Hypovolaemic shock	1.2% 1/86 • Number of events 1 • 30 days
Vascular disorders Intra-abdominal haematoma	1.2% 1/86 • Number of events 1 • 30 days

Other adverse events

Measure	Treatment Arm n=86 participants at risk All study subjects will be treated using the CleanCision device.
Gastrointestinal disorders Vomiting	5.8% 5/86 • Number of events 5 • 30 days
Infections and infestations Urinary tract infection	5.8% 5/86 • Number of events 5 • 30 days

Additional Information

Director of Clinical

Prescient Surgical

Phone: 6504895025

Email: lclaude@prescientsurgical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60