Trial Outcomes & Findings for Perfusion Assessment in Laparoscopic Left Anterior Resection (NCT NCT01560377)
NCT ID: NCT01560377
Last Updated: 2018-12-11
Results Overview
To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
147 participants
Primary outcome timeframe
Day of Operation - Day 1
Results posted on
2018-12-11
Participant Flow
A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Patients were enrolled at 11 centers in the United States.
Participant milestones
| Measure |
Subjects Imaged With PINPOINT
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
|
|---|---|
|
Overall Study
STARTED
|
147
|
|
Overall Study
Eligible for Analysis
|
139
|
|
Overall Study
COMPLETED
|
147
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perfusion Assessment in Laparoscopic Left Anterior Resection
Baseline characteristics by cohort
| Measure |
Subjects Imaged With PINPOINT
n=139 Participants
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
139 participants
n=5 Participants
|
|
ASA Classification (American Society of Anesthesiologists)
I (normal healthy patient)
|
17 Participants
n=5 Participants
|
|
ASA Classification (American Society of Anesthesiologists)
II (patient with mild systemic disease)
|
73 Participants
n=5 Participants
|
|
ASA Classification (American Society of Anesthesiologists)
III (patient with severe systemic disease)
|
46 Participants
n=5 Participants
|
|
ASA Classification (American Society of Anesthesiologists)
IV (severe life threating systemic disease)
|
3 Participants
n=5 Participants
|
|
BMI
BMI > 30 kg/m^2
|
42 Participants
n=5 Participants
|
|
BMI
BMI < 30 kg/m^2
|
97 Participants
n=5 Participants
|
|
Preoperative chemotherapy
Yes
|
13 Participants
n=5 Participants
|
|
Preoperative chemotherapy
No
|
126 Participants
n=5 Participants
|
|
Preoperative radiation therapy
Yes
|
15 Participants
n=5 Participants
|
|
Preoperative radiation therapy
No
|
124 Participants
n=5 Participants
|
|
Diagnosis
Diverticulitis
|
61 Participants
n=5 Participants
|
|
Diagnosis
Rectal cancer
|
35 Participants
n=5 Participants
|
|
Diagnosis
Colon cancer
|
29 Participants
n=5 Participants
|
|
Diagnosis
Polyp
|
6 Participants
n=5 Participants
|
|
Diagnosis
Procidentia
|
4 Participants
n=5 Participants
|
|
Diagnosis
Crohn's disease
|
1 Participants
n=5 Participants
|
|
Diagnosis
Colovesical fistula
|
1 Participants
n=5 Participants
|
|
Diagnosis
Radiation stricture
|
1 Participants
n=5 Participants
|
|
Diagnosis
Sigmoid volvulus
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of Operation - Day 1To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
Outcome measures
| Measure |
Subjects Imaged With PINPOINT
n=139 Participants
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
|
|---|---|
|
PINPOINT System Utility in Left Colectomy Surgery
Change to surgical plan due to Fluorescence
|
11 Participants
|
|
PINPOINT System Utility in Left Colectomy Surgery
No change to surgical plan due to Fluorescence
|
128 Participants
|
SECONDARY outcome
Timeframe: Through hospital discharge or at 30 days post procedure, whichever is laterTo assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.
Outcome measures
| Measure |
Subjects Imaged With PINPOINT
n=139 Participants
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
|
|---|---|
|
Safety of the PINPOINT System
Clinical anastomotic leak & confirmed by radiology
|
2 Participants
|
|
Safety of the PINPOINT System
Post-operative fever
|
7 Participants
|
|
Safety of the PINPOINT System
Delay in return of bowel function
|
5 Participants
|
|
Safety of the PINPOINT System
No major post-operative clinical complication
|
125 Participants
|
Adverse Events
Subjects Imaged With PINPOINT
Serious events: 23 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects Imaged With PINPOINT
n=139 participants at risk
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
|
|---|---|
|
Surgical and medical procedures
Anastomotic leak
|
1.4%
2/139
|
|
Infections and infestations
Pelvic abscess
|
1.4%
2/139
|
|
Infections and infestations
Abdominal wall infection
|
0.72%
1/139
|
|
Renal and urinary disorders
Acute renal failure
|
0.72%
1/139
|
|
Blood and lymphatic system disorders
Blood transfusion
|
0.72%
1/139
|
|
Infections and infestations
C. difficile colitis
|
1.4%
2/139
|
|
General disorders
Fever
|
0.72%
1/139
|
|
Gastrointestinal disorders
Ileus
|
0.72%
1/139
|
|
Gastrointestinal disorders
Ileus requiring nasogastric tube
|
0.72%
1/139
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.72%
1/139
|
|
Gastrointestinal disorders
Incisional hernia
|
0.72%
1/139
|
|
Vascular disorders
Thrombosed left renal artery
|
0.72%
1/139
|
|
Renal and urinary disorders
Urinary retention
|
0.72%
1/139
|
|
Renal and urinary disorders
Urinary tract infection
|
0.72%
1/139
|
|
Infections and infestations
Wound infection
|
0.72%
1/139
|
|
Cardiac disorders
Hypertension
|
0.72%
1/139
|
|
Hepatobiliary disorders
Hypokalemia
|
0.72%
1/139
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/139
|
|
Gastrointestinal disorders
Constipation
|
0.72%
1/139
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60