Trial Outcomes & Findings for Endostapler Sleeve Gastrectomy Study (NCT NCT04617574)

Results Overview

Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

Within surgery, after the last stapler firing

Results posted on

2021-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	AEON Endostapler Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology	Total n=60 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 16.0 • n=30 Participants	42.8 years STANDARD_DEVIATION 11.1 • n=30 Participants	43.0 years STANDARD_DEVIATION 13.6 • n=60 Participants
Sex: Female, Male Female	25 Participants n=30 Participants	27 Participants n=30 Participants	52 Participants n=60 Participants
Sex: Female, Male Male	5 Participants n=30 Participants	3 Participants n=30 Participants	8 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	39.5 kg/m^2 STANDARD_DEVIATION 5.4 • n=30 Participants	39.4 kg/m^2 STANDARD_DEVIATION 5.3 • n=30 Participants	39.5 kg/m^2 STANDARD_DEVIATION 5.3 • n=60 Participants

PRIMARY outcome

Timeframe: Within surgery, after the last stapler firing

Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.

Outcome measures

Outcome measures
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Intraoperative Endoscopic Staple Line Bleeding Score	1.63 score on a scale Standard Deviation .57	2.00 score on a scale Standard Deviation .55

PRIMARY outcome

Timeframe: Within surgery, images captured 10 seconds after the last stapler firing

Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.

Outcome measures

Outcome measures
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Intraoperative Laparoscopic Staple Line Bleeding Score	1.55 score on a scale Standard Deviation .67	1.98 score on a scale Standard Deviation .74

SECONDARY outcome

Timeframe: Within 30-day post-operative period

Number of participants with postoperative leakage requiring intervention

Outcome measures

Outcome measures
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Number of Participants With Postoperative Leakage Requiring Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 72 hours of surgery start time

Number of participants with intraoperative or postoperative blood transfusion

Outcome measures

Outcome measures
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Number of Participants With Intraoperative or Postoperative Blood Transfusion	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30-day post-operative period

Number of participants with reported device-related adverse events

Outcome measures

Outcome measures
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Number of Participants With Reported Device-related Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within surgery

Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.

Outcome measures

Outcome measures
Measure	AEON Endostapler n=30 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Endo GIA Reloads With Tri-Staple Technology n=30 Participants Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology
Number of Participants With Product Malfunction	0 Participants	0 Participants

Adverse Events

AEON Endostapler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endo GIA Reloads With Tri-Staple Technology

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bariatric Clinical Administrator

Holyoke Medical Center Weight Management Program

Phone: (413) 535 - 4759

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place